Apparatus and method for regulating tissue welder jaws

ABSTRACT

A surgical apparatus and methods for severing and welding tissue, in particular blood vessels. The apparatus includes an elongated shaft having a pair of relatively movable jaws at a distal end thereof. A first heating element on one of the jaws is adapted to heat up to a first temperature and form a welded region within the tissue, while a second heating element on one of the jaws is adapted to heat up to a second temperature and sever the tissue within the welded region. The first and second heating elements may be provided on the same or opposite jaws. A control handle provided on the proximal end of the elongated shaft includes controls for opening and closing the jaws, and may include an actuator for sending current through the first and second heating elements. The first and second heating elements may be electrically connected in series, and the first heating element may be bifurcated such that it conducts about one half of the current as the second heating element. A force-limiting mechanism provided either within the control handle, in the elongated shaft, or at the jaws limits the pressure applied to the tissue by the jaws to ensure that the tissue is severed and the ends effectively welded within a short amount of time.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/629,423, filed on Feb. 23, 2015, which is a continuation of U.S.patent application Ser. No. 14/148,671, filed on Jan. 6, 2014 (nowissued as U.S. Pat. No. 9,610,113 B2), which is a continuation of U.S.patent application Ser. No. 13/549,367, filed on Jul. 13, 2012, nowissued as U.S. Pat. No. 8,623,003 on Jan. 7, 2014, which is acontinuation of U.S. patent application Ser. No. 13/047,778, filed onMar. 14, 2011, now abandoned, which is a continuation of U.S. patentapplication Ser. No. 11/090,330, filed Mar. 25, 2005, now issued as U.S.Pat. No. 7,918,848 on Apr. 5, 2011. The entire disclosures of all of theabove applications are expressly incorporated by reference herein.

The present application relates to application Ser. No. 11/090,750,filed Mar. 25, 2005, now U.S. Pat. No. 8,197,472, the entire disclosureof which is expressly incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to surgical devices and methods forsevering and sealing blood vessels and, in particular, to an endoscopictissue welder.

BACKGROUND OF THE INVENTION

Endoscopic harvesting of vessels is well known in the surgical field andhas been the subject of a great deal of recent technologicaladvancement. Typically, the harvested vessel is used for bypass or as ashunt around an artery that has diminished flow from stenosis or otheranomaly, such as a Coronary Artery Bypass Grafting (CABG) procedure.Often in CABG, a saphenous vein from the patient's leg is harvested forsubsequent use in the surgery. Other vessels, such as the radial artery,can also be harvested and used in this manner. Vessel harvestinginvolves liberating the vessel from surrounding tissue and transectingsmaller side branches, cauterizing, tying or ligating the vessel at aproximal site and a distal site, and then transecting the vessel at bothsites before it is removed from the body.

Known endoscopic methods and devices for performing vessel harvestingare discussed in detail in U.S. Pat. No. 6,176,895 to Chin, et al., Re36,043 to Knighton, U.S. Pat. No. 6,406,425 to Chin, et al., and U.S.Pat. No. 6,471,638 to Chang, et al., all of which are expresslyincorporated herein by reference. Furthermore, various devices andmethods disclosed in U.S. Pat. No. 5,895,353 to Lunsford, et al., andU.S. Pat. No. 6,162,173 to Chin, et al., and pending patent applicationSer. No. 10/602,490 entitled “Apparatus and Method for Integrated VesselLigator and Transector” are also expressly incorporated herein byreference. Also, commercial vessel harvesting systems sold under thetradename VASOVIEW® Uniport Plus and VASOVIEW® 5 are available fromGuidant Corporation of Santa Clara, Calif.

Numerous instruments are known which coagulate, seal, join, or cuttissue, and which are suitable, for example, for severing a targetvessel from surrounding side branches and securing the separated ends tostanch bleeding. Such devices typically comprise a pair of tweezers,jaws or forceps that grasp onto and hold tissue there between. Thedevices may operate with a heating element in contact with the tissue,with an ultrasonic heater that employs frictional heating of the tissue,or with a mono- or bi-polar electrode heating system that passes currentthrough the tissue such that the tissue is heated by virtue of its ownelectrical resistance. The devices heat the tissue to temperatures suchthat the tissue is either “cut” or “sealed”, as follows. When tissue isheated in excess of 100° Celsius, the tissue disposed between thetweezers, jaws or forceps will be broken down and is thus, “cut”.However, when the tissue is heated to temperatures between 50° to 90°Celsius, the tissue will instead simply “seal” or “weld” to adjacenttissue. In the context of the present application, the term “tissuewelding” refers to procedures that cause otherwise separated tissue tobe sealed, coagulated, fused, welded or otherwise joined together.Numerous devices employing the same general principle of controlledapplication of a combination of heat and pressure can be used to join or“weld” adjacent tissues to produce a junction of tissues or ananastomosis of tubular tissues.

Monopolar and bipolar probes, forceps or scissors use high frequencyelectrical current that passes through the tissue to be coagulated. Thecurrent passing through the tissue causes the tissue to be heated,resulting in coagulation of tissue proteins. In the monopolar variety ofthese instruments, the current leaves the electrode and after passingthrough the tissue, returns to the generator by means of a “groundplate” which is attached or connected to a distant part of the patient'sbody. In a bipolar version of such an electro-surgical instrument, theelectric current passes between two electrodes with the tissue beingplaced or held between the two electrodes as in the “Kleppinger bipolarforceps” used for occlusion of Fallopian tubes. There are many examplesof such monopolar and bipolar instruments commercially available todayfrom companies including Valley Lab, Cabot, Meditron, Wolf, Storz andothers worldwide.

A new development in this area is the “Tripolar” instrument marketed byCabot and Circon-ACMI which incorporates a mechanical cutting element inaddition to monopolar coagulating electrodes. A similar combined sealingand mechanical cutting device may also be known as a tissue “bisector,”which merges the terms bipolar cautery and dissector. One tissuebisector is packaged for sale as an element of the VASOVIEW® UniportPlus and VASOVIEW® 5 vessel harvesting systems by Guidant Corporation ofSanta Clara, Calif.

In ultrasonic tissue heaters, a very high frequency (ultrasonic)vibrating element or rod is held in contact with the tissue. The rapidvibrations generate heat causing the proteins in the tissue to becomecoagulated.

Conductive tissue welders usually include jaws that clamp tissue therebetween, one or both of which are resistively heated. In this type ofinstrument, no electrical current passes through the tissue, as is thecase for monopolar or bipolar cautery. Some tissue welders also performa severing function without a mechanical knife. For example, the ThermalLigating Shears made by Starion Instruments of Saratoga, Calif. is a,hand activated instrument that utilizes thermal welding tosimultaneously seal and divide soft tissue during laparoscopic generalsurgery procedures. The Starion device uses a heating element at the tipof one of a pair of facing jaws combined with pressure to denature theprotein molecules within the tissue. The denatured proteins bondtogether, forming an amorphous mass of protein, and fusing tissue layerstogether. The procedure can be used to fuse vessels closed. More highlyfocused heat may be applied in the center of the tissue within the jawsof the instrument, causing the tissue or vessel to divide, thusresulting in two sealed ends. A description of the Starion device isprovided at www.starioninstruments.com.

Despite accepted means for severing and securing vessels, such as in avessel harvesting procedure, there remains a need for an improved devicethat increases the operating efficiency of the device and ensures theleast amount of trauma to surrounding tissue while simultaneouslyproviding repeatable secure sealing of the severed vessel ends.

SUMMARY OF THE INVENTION

The present invention provides designs of tissue severing/sealingdevices that control the pressure applied to tissue between the distaljaws to avoid crushing an improved the severing and welding process.

In one embodiment, the present invention includes a surgical apparatusfor welding and severing tissue comprising first and second relativelymovable elongated jaws having facing surfaces. The first and secondrelatively movable jaws attach to a distal end of an elongated shaft,and at least one heating element is provided on the facing surface ofone of the first or second jaws. A control handle connects to theelongated shaft, and a control actuator alternately separates and bringstogether the facing surfaces of the elongated jaws. Finally, aforce-limiting mechanism interposed between the control actuator and thejaws regulates the magnitude of closing force of the jaws to betweenabout 1-3 lbs. (0.45-1.36 kg) to ensure the heating element effectivelywelds and severs tissue held within the facing surfaces of the closedelongated jaws. In an alternative arrangement, the force-limitingmechanism regulates the magnitude of closing force of the jaws so thatthe heating element effectively welds and severs tissue held within thefacing surfaces of the closed elongated jaws within a time frame of 5seconds or less. In a preferred embodiment, a second heating element isprovided on the facing surface of one of the first or second jaws,wherein the first heating element is adapted to weld tissue and thesecond heating element is adapted to sever tissue.

Desirably, a control rod extends from the control handle to the distalend of the elongated shaft and connects to translate movement of thecontrol actuator into movement of the jaws. In one configuration, theforce-limiting mechanism comprising a spring mounted coaxially on thecontrol rod. The spring may be located within the elongated shaft, andmay even be formed by a portion of the control rod such as a helicallaser cut within a tubular control rod. In addition, a second spring maymount coaxially on the control rod and be arranged such that deformationof the first and second springs does not occur simultaneously uponclosing of the jaws. In a second configuration, the force-limitingmechanism comprises a spring located within the control handle. Forexample, the control actuator may comprise a toggle journalled to pivotin two directions and accordingly displace the control rod in oppositedirections, wherein the spring is arranged to affect relative movementof the toggle and the control rod in one direction of pivot of thetoggle. Alternatively, the force-limiting mechanism includes aball-detent structure arranged to decouple (or clutch) relative movementof the toggle and the control rod in one direction of pivot of thetoggle at a predetermined reaction force transmitted through the controlrod from closing of the jaws.

In accordance with an alternative configuration, the force-limitingmechanism comprises an elastic member incorporated within the jaws. Forexample, the elastic member may be bi-metallic springs adapted to changeshape at elevated temperatures. Or, the elastic member may be acompliant layer on at least one of the jaws. In another arrangement, theelastic member comprises a spring positioned between the proximal endsof two jaws which permits the proximal ends to separate at apredetermined force impeding further closing movement of the jaws.

In one embodiment, the jaws are mounted in parallel on the end of theelongated shaft, wherein the apparatus further includes structure formaintaining the parallelism of the jaws during opening and closingthereof.

Another aspect of the invention is a surgical method of severing atarget tissue while welding the severed ends. The method first includesproviding a surgical apparatus for welding tissue including a pair ofjaws having facing surfaces adapted to open and close upon the targettissue, at least one of the jaws including an electrically-resistiveheating element on its facing surface. The jaws are closed upon a targettissue, and the magnitude of closing force of the jaws is limited to avalue calibrated to ensure the heating element effectively severs andwelds tissue held within the facing surfaces of the jaws within a timeframe of about 5 seconds or less. The first heating element is energizedto form a welded region in the target tissue and sever the target tissuewithin the welded region. Preferably, the step of limiting the magnitudeof closing force of the jaws comprises regulating the magnitude ofclosing force of the jaws to between about 1-3 lbs. (0.45-1.36 kg). Inaddition, a second resistive heating element for severing tissue may beprovided on the facing surface of one of the first or second jaws, themethod including electrically energizing the second heating element tosever the target tissue within the welded region.

The method may also include maintaining parallelism between the jawsduring the step of closing the jaws upon target tissue. Desirably, thesurgical apparatus further includes a control handle having a controlactuator for opening and closing the jaws. In one embodiment, thestructure between the control actuator and the jaws completely decouplesrelative movement of the control actuator and the jaws at apredetermined closing force. In this case, the method includes closingthe jaws until the predetermined closing force has been reached so thatmovement of the jaws is decoupled from further movement of the controlactuator. Alternatively, the structure between the control actuator andthe jaws influences relative movement of the control actuator and thejaws at a predetermined closing force. In the latter instance, themethod includes closing the jaws until the predetermined closing forcehas been reached so that the closing force applied by the jaws on thetarget tissue remains constant even with further movement of the controlactuator.

Another desirable aspect of the present invention is a surgicalapparatus for welding tissue comprising an elongated shaft having ameans for cauterizing tissue attached to a distal end thereof, the shafthaving an internal channel along its length for passage of gas. Acontrol handle connects to the elongated shaft, and a passive filtermounts within the control handle to intercept gas passing in a proximaldirection through the channel of the elongated shaft so as to filter thegas before it is released to the interior of the control handle or theenvironment. The means for cauterizing tissue may comprise a pair ofjaws for closing on tissue, and preferably one of the jaws has anelectrically-resistive heating element thereon. In a preferredembodiment, the elongated shaft has at least one port formed thereinwithin the control handle open to the internal channel, and wherein thepassive filter comprises a hollow permeable member arranged around theelongated shaft at the port. The passive filter may comprise a tubularmember sealed at both ends around the elongated shaft and having anenlarged hollow cavity therein adjacent to which the port vents. Theapparatus also incorporate means for insufflating a body cavity suchthat a positive pressure within the body cavity forces gas in a proximaldirection through the internal channel of the elongated shaft.

A further alternative aspect of the invention is a surgical apparatusfor welding tissue comprising first and second relatively movableelongated jaws having facing surfaces. The relatively movable jawsattach to a distal end of an elongated shaft, and at least one heatingelement is provided on the facing surface of one of the jaws. A controlhandle connects to the elongated shaft and a control actuator mounts onthe handle for alternately separating and bringing together the facingsurfaces of the elongated jaws. A control rod extends from the controlhandle to the distal end of the elongated shaft and connects totranslate movement of the control actuator into movement of the jaws.Finally, an electromotive actuator interposed between the controlactuator and the jaws displaces the control rod.

In a still further aspect, the invention includes a surgical apparatusfor welding tissue comprising first and second relatively movableelongated jaws having facing surfaces. The relatively movable jawsattach to a distal end of an elongated shaft, and at least one heatingelement is provided on the facing surface of one of the jaws. A controlhandle connects to the elongated shaft and a control actuator mounts onthe handle for alternately separating and bringing together the facingsurfaces of the elongated jaws. Additionally, a compliant layer on oneof the elongated jaws deforms upon jaw closing and limits the magnitudeof closing force of the jaws. In one configuration, the compliant layeris provided as a middle layer on one of the jaws with a rigid tissuecontacting plate to the inside of the jaw that contacts tissue. Upon jawclosing, the compliant middle layer compresses to a greater extent atits proximal end such that the rigid tissue contacting plate floats onthe jaw and helps even out clamping pressure on the tissue. In analternative configuration, the compliant layer comprises a tissuecontacting surface of one of the jaws, and the opposite jaw includes aheating element that projects inward from that jaw, wherein thecompliant layer conforms to the shape of the heating element on theopposite jaw when the jaws are closed.

In a still further aspect of the invention, a surgical apparatus forwelding tissue comprises first and second relatively movable elongatedjaws having facing surfaces. The relatively movable jaws attach to adistal end of an elongated shaft, and at least one heating element isprovided on the facing surface of one of the jaws. A control rod extendsfrom the control handle to the distal end of the elongated shaft andconnected to translate movement of the control actuator into movement ofthe jaws. Finally, a control handle connects to the elongated shaft anda control actuator mounts on the handle for alternately separating andbringing together the facing surfaces of the elongated jaws. The controlactuator includes a cam slot that receives a member connected to thecontrol rod, the cam slot being shaped to displace the control rod at anon-linear rate. Preferably, the cam slot is shaped such that as thejaws begin to come together their rate of closure decreases, and as thejaws begin to open their rate of separation increases.

In accordance with a still further aspect of the invention, a surgicalapparatus for welding tissue comprises first and second relativelymovable elongated jaws having facing surfaces. The relatively movablejaws attach to a distal end of an elongated shaft, and at least oneheating element is provided on the facing surface of one of the jaws. Acontrol handle connects to the elongated shaft and a control actuatormounted on the handle alternately separates and brings together thefacing surfaces of the elongated jaws. Each of the jaws has a transversewidth, and one of the jaws has a transverse width that is at least 20%less than the transverse width of the other jaw.

Another aspect of the invention is a surgical apparatus for weldingtissue comprising first and second relatively movable elongated jawscomprising inner jaw members surrounded by tissue-resistant boots,wherein the shape of at least one of the boots on its surface that facesthe other jaw is convex. The relatively movable jaws attach to a distalend of an elongated shaft, and at least one heating element is providedon the facing surface of one of the jaws. A control handle connects tothe elongated shaft and a control actuator mounts on the handle foralternately separating and bringing together the elongated jaws. In oneconfiguration, the shape of each boot on its surface that faces theother jaw is convex. Preferably both boots have an outer surface shapedsubstantially as semi-circles with the rounded portions facing oneanother.

In accordance with another aspect of the invention, a surgical apparatusfor welding tissue includes first and second relatively movableelongated jaws having facing surfaces. The relatively movable jawsattach to a distal end of an elongated shaft, and at least one heatingelement is provided on the facing surface of one of the jaws. A controlhandle connects to the elongated shaft and a control actuator mounts onthe handle for alternately separating and bringing together the facingsurfaces of the elongated jaws. A fluid-mechanical driver connectsbetween the control actuator and the jaws and translates movement of thecontrol actuator into movement of the jaws.

A further aspect of the invention is a surgical apparatus for weldingtissue comprising first and second relatively movable elongated jawscomprising inner jaw members surrounded by tissue-resistant boots. Therelatively movable jaws attach to a distal end of an elongated shaft,and there is at least one heating element embedded in the boot of one ofthe first or second jaws. A control handle connects to the elongatedshaft and a control actuator mounts on the handle for alternatelyseparating and bringing together the elongated jaws.

Still further, another aspect of the invention comprises a surgicalapparatus for severing tissue with first and second relatively movableelongated jaws having facing surfaces. The relatively movable jawsattach to a distal end of an elongated shaft, and at least one heatingelement is provided on the facing surface of one of the jaws. A controlhandle connects to the elongated shaft and a control actuator mounts onthe handle for alternately separating and bringing together the facingsurfaces of the elongated jaws. At least one flap projects from one ofthe jaws to overlap to the side of the opposite jaw when the jaws closeand help push tissue from the jaws. Desirably, each jaw comprises aninner jaw member surrounded by a tissue-resistant boot, wherein each ofthe boots includes one of the flaps that projects to overlap to the sideof the opposite jaw.

In accordance with still another aspect, a surgical apparatus forwelding tissue is provided including first and second relatively movableelongated jaws having facing surfaces. The relatively movable jawsattach to a distal end of an elongated shaft, and at least one heatingelement is provided on the facing surface of one of the jaws. A controlhandle connects to the elongated shaft and a control actuator mounts onthe handle for alternately separating and bringing together the facingsurfaces of the elongated jaws. The control handle includes structuretherewithin for temporarily locking motion of the control actuator atthe extent of its movement when the jaws are closed. Preferably, thecontrol actuator comprises a toggle adapted for pivoting movement withinthe control handle. The structure for temporarily locking motion of thetoggle may comprise a pin on the toggle that rides in an L-shapedchannel formed within the control handle, and a spring that biases thetoggle into a short angled portion of the channel. Alternatively, thestructure for temporarily locking motion of the toggle comprises afeature on the toggle that engages a pin fixed within the controlhandle.

Still further, the present invention provides a surgical apparatus forcutting tissue comprising first and second relatively movable elongatedjaws having facing surfaces. The relatively movable jaws attach to adistal end of an elongated shaft, and at least one heating element isprovided on the facing surface of one of the jaws for cutting throughtissue when the jaws are open. A control handle connects to theelongated shaft and a control actuator mounts on the handle foralternately separating and bringing together the facing surfaces of theelongated jaws. A control rod extends from the control handle to thedistal end of the elongated shaft and connects to translate movement ofthe control actuator into movement of the jaws. The control actuatorincludes a cam lobe that acts on the control rod and has a shape that,when displaced in one direction, opens the jaws to their maximum widthand then slightly closes them to control the angle of the jaws relativeto one another for improved cutting.

In a final aspect, the present invention provides a surgical apparatusfor welding tissue comprising first and second relatively movableelongated jaws having facing surfaces. The relatively movable jawsattach to a distal end of an elongated shaft, and at least one heatingelement is provided on the facing surface of one of the jaws for cuttingthrough tissue when the jaws are open. A control handle connects to theelongated shaft and a control actuator mounts on the handle foralternately separating and bringing together the facing surfaces of theelongated jaws. The apparatus further includes a circuit for energizingthe heating element, the circuit having a safety interlock switchactuated on movement of the control actuator to fully close the jaws.Desirably, the safety interlock switch comprises at least one conductivepad mounted on the control actuator that contacts another conductive padmounted within the control handle. Alternatively, the safety interlockswitch comprises a switch, possibly a micro-switch, mounted within thecontrol handle in the path of movement of the control actuator.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C are perspective views of a modular handle unit of a vesselharvesting system including a sled/adapter that permits a multipurposehandle base of the system to receive a tissue severing/welding device ofthe present invention;

FIGS. 2A-2B are perspective views of the distal end of an exemplarytissue severing/welding device of the present invention showing a pairof clamping jaws in their closed position;

FIGS. 3A-3B are perspective views of the distal end of the tissuesevering/welding device of FIGS. 2A-2B showing the clamping jaws intheir open position;

FIG. 4 is an exploded perspective view of the distal end of the tissuesevering/welding device of FIGS. 2A-2B;

FIGS. 5A-5B are perspective views of a “hot” jaw used in the exemplarytissue severing/welding device of the present invention;

FIGS. 6A-6B are enlarged perspective views of a proximal subassembly ofthe “hot” jaw of FIGS. 5A-5B;

FIGS. 7A-7C are perspective views of an exemplary heating elementsubassembly of the “hot” jaw of FIGS. 5A-5B;

FIGS. 8A-8H are perspective, plan, and elevational views of an exemplaryinner jaw forming a portion of the “hot” jaw of FIGS. 5A-5B;

FIGS. 9A-9E are perspective, plan, and elevational views of an exemplaryheating element for welding tissue used in the “hot” jaw of FIGS. 5A-5B;

FIGS. 10A-10H are perspective, plan, and elevational views of anexemplary boot for covering the inner jaw of FIGS. 8A-8H;

FIG. 11A is a perspective view of a proximal control handle of anexemplary tissue severing/welding device of the present invention;

FIGS. 11B-11C are opposite longitudinal sectional views of the controlhandle of FIG. 11A including a passive smoke filter therein;

FIGS. 11D-11F illustrate control handles having alternative smoke filterconfigurations;

FIG. 12 is a perspective exploded view of the proximal control handle ofFIG. 11A;

FIG. 13A is a perspective view of an alternative control handle of thepresent invention;

FIGS. 13B-13C are opposite longitudinal sectional views of the controlhandle of FIG. 13A;

FIGS. 14A-14C are elevational views of pair of jaws in open and closedpositions that illustrate a preferred jaw opening mechanism of thepresent invention;

FIGS. 15A and 15B schematically illustrate an exemplary force-limitinginterface between an actuator of a control handle and a control rod thatregulate the opening and closing of distal tissue welding jaws;

FIGS. 16A and 16B schematically illustrate another exemplaryforce-limiting interface in a toggle-like actuator of a control handle;

FIGS. 17A and 17B schematically illustrate another exemplaryforce-limiting interface in a toggle-like actuator of a control handle;

FIG. 18 schematically illustrates another exemplary force-limitinginterface in a toggle-like actuator of a control handle;

FIG. 19 schematically illustrates another exemplary force-limitinginterface between an actuator of a control handle and a control rod thatforms a part of a toggle-like actuator and completely decouples movementof the control rod from further movement of the toggle beyond apredetermined reaction force;

FIG. 20 schematically illustrates another exemplary force-limitinginterface between an actuator of a control handle and a control rod thatalso decouples movement of the control rod from further movement of thetoggle beyond a predetermined reaction force;

FIG. 21 is a schematic view of a tubular control rod having a helicalforce-limiting spring cut therein;

FIGS. 22A and 22B schematically illustrate alternative exemplaryforce-limiting structures to control the opening and closing of distaltissue welding jaws located within an elongated shaft of the tissuewelder;

FIG. 23 is a schematic view of a solenoid for displacing a control rodand limiting the force applied thereby;

FIGS. 24-25, 26A, and 26B are schematic views of distal tissue weldingjaws that are structured therein for limiting the amount force that canbe applied thereby to tissue;

FIG. 27 is a schematic depiction of the mechanism for maintainingparallelism of tissue welding jaws;

FIG. 28 is a schematic depiction of a proximal end of tissue weldingjaws having a spring between their respective pivot points for bothlimiting the force that can be applied thereby and helping to maintainparallelism of the jaws;

FIG. 29 is a schematic illustration of an actuator having a cam slotthat acts on a control rod for displacing the control rod in anon-linear fashion;

FIGS. 30A and 30B are cross-sectional views of symmetric tissue weldingjaws;

FIGS. 31A and 31B are cross-sectional views of asymmetric tissue weldingjaws;

FIG. 32 is a cross-sectional view of symmetric tissue welding jaws, oneof which has a heating element thereon;

FIG. 33 is a cross-sectional view of symmetric tissue welding jawshaving insulating boots that are reversed to present roundedtissue-contacting surfaces;

FIGS. 34A and 34B are schematic views of tissue welding jaws, one ofwhich has a malleable facing surface and the other which has a contouredheating element thereon;

FIGS. 35 and 36 are graphs of temperature and pressure, respectively,across the width of tissue held within the jaws of FIGS. 34A and 34B;

FIG. 37 is a cross-sectional view of an exemplary pair of tissue weldingjaws, one of which has two heating elements thereon;

FIG. 38 is a cross-section sectional view of an alternative pair oftissue welding jaws both of which have heating element thereon;

FIG. 39 is a cross-section sectional view of a tissue welding jaw havinga heating element embedded within an insulating boot to provide smoothtransitions there between;

FIGS. 40A and 40B are schematic perspective views of a pair of tissuewelding jaws having tissue severing flaps;

FIGS. 41A and 41B, and 42A and 42B are schematic views of alternativeactuator toggles each having a mechanism for locking the toggle at oneend of its travel;

FIGS. 43A and 43B are schematic views of an actuator toggle and camsurface that acts on a control rod to angle the distal tissue weldingjaws for fasciotomy.

FIG. 44 shows a toggle or actuator;

FIG. 45 shows a safety interlock;

FIG. 46 shows another alternative wherein an actuator carries aprotrusion that acts on a leaf spring to close a safety interlockcircuit;

FIGS. 47A-47B show another safety interlock; and

FIGS. 48A-48B show another safety interlock.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

According to one aspect of the present invention devices and methods forsealing, or coagulating, and severing tissue during surgery areprovided. The instruments incorporate means for controllably heatingtissue while simultaneously applying a definite and controllable amountof pressure to the tissue being heated. Because of the combinedapplication of heat and pressure, tissue proteins will become coagulatedand blood vessels within the tissue will be sealed shut, achievinghemostasis. Optimal sealing or coagulating tissue means producing astrong and durable seal or coagulation or anastomosis with a minimalamount of collateral tissue damage.

One aspect of the present invention includes a method and system for thesurgical treatment of biological tissue, wherein thermal energy andpressure are applied simultaneously, substantially simultaneously,consecutively, or alternatively, over a time such that tissue proteinsare denatured and the tissue will adhere or join to itself or to othertissues, for the purpose of coagulating bleeding, sealing tissue,joining tissue and cutting tissue. The minimum amount of heat or thermalenergy needed to accomplish these goals is expended, so as to minimizethermal damage to tissue adjacent to the treated site.

The devices of the invention may also incorporate means for cutting, orsevering the tissue. “Severing” includes dissecting or tissue division,tissue disruption or separation, plane development, or definition, ormobilization of tissue structures in combination with a coagulation, orhemostasis or sealing of blood vessels or other tissue structures suchas lymphatics, or tissue joining. Severing can be achieved by use ofamounts of heat greater than the amount required to coagulate thetissues, yet a minimum amount of energy is used with the least amount ofunwanted tissue necrosis. In conjunction with some aspect of theinvention, severing can be achieved by other mechanical, ultrasonic, orelectronic means, including, but not limited to, shearing action, laserenergy, and RF, or a combination of two or more of the above. Forexample, a blade may be passed through the coagulated tissue while thetissue is being held in the jaws of the instrument.

The present invention desirably provides a tissue welder that can beincorporated as a component of an integrated vessel harvesting system,such as is disclosed in application Ser. No. 10/951,426, filed Sep. 28,2004, which is expressly incorporated herein by reference. The vesselharvesting system is especially useful in minimally invasive endoscopicharvesting of blood vessels, including harvesting of internal thoracicartery, or vessels of the extremities along the radial artery in the armfor use in coronary artery bypass grafting, and the saphenous vein inthe leg for use in both coronary artery bypass grafting and peripheralartery bypass. In this context, the tissue welder performs both asevering and securing/welding function in separating side branches fromthe target vessel that is being harvested. It should be understood,however, that various aspects of the tissue welder described herein maybe utilized in conjunction with other surgical systems for coagulatingand/or dissecting tissue.

The exemplary embodiment of the tissue welder of the present inventioncomprises a so-called “welding and severing device” that is used toclose off and separate side branches from a primary vessel beingharvested, and also possibly to sever the primary vessel. However, thedevice is disclosed herein are suitable for welding and severing tissuein general not just vessels. In its broadest sense, the term tissuewelding and severing device refers to any and all devices thataccomplish a single function or any combination of the functions ofwelding, ligating, cauterizing, coagulating and/or sealing, and severingor transecting target tissue. For example, electrocautery tools such asbipolar scissors (or other plural electrode-based devices), monopolardevices, tissue bisectors, or other such devices provide these functionsalone or in conjunction with an integral blade or cutter. Other similardevices using various acceptable sources of energy for sealing thetissue (for example, RF, microwave, laser, ultrasound, direct thermalenergy, etc.) are also within the scope of the present invention. Eachdevice that acts on tissue to either weld or sever it will be termed anenergy applicator. The welding and severing device could be a singletool or a combination of plurality of separate tools each having its ownfunction useful in tissue severing, or more specifically in vesselharvesting.

Parenthetically, it is important to note that, while each of the variousaspects of the present invention may be used to advantage in combinationwith the other aspects, each is believed to also be of patentablesignificance when used alone with otherwise conventional systems andtechniques. Thus, the tissue welding devices and methods may beimplemented using heating and control structures other than thosedisclosed herein, and in the context of systems other than those forvessel harvesting. Furthermore, various aspects of the tissue welderdisclosed herein may be utilized with other welding and severingdevices, such as bipolar scissors or tissue bisectors. Similarly,certain aspects of the coagulation function of the tissue welder may becombined with a mechanical cutter to provide the severing function.

Finally, it should be understood that the exemplary and/or alternativetissue welders and features described herein have numerous applicationsin addition to vessel harvesting. For example, a tissue welder may beutilized in gastric bypass surgery to resect and close a portion of thestomach. Similarly, volume reduction of the lungs in patients withemphysema can also be accomplished with the devices disclosed herein.Bowel resection is another potential application. Other surgicalprocedures include: femoral popliteal bypass; severing/ligatingepigastric arteries for gastric reflux disease; fallopian tube ligation;vasectomies; severing/ligating arteries, veins, and bile ducts ingallbladder removal surgery; and nephrectomies where the ureters leadingto the kidney are transected and ligated.

FIGS. 1A-1C illustrate a modular handle unit 20 of an exemplary vesselharvesting system comprising a mating handle base 22 and handle sled 24.The handle base 22 includes a distal flange 26 secured to an elongatedcannula 28. The cannula 28 is sized to extend into a body cavity andprovides a channel for various vessel harvesting tools. The handle sled24 includes structure for mating with the handle base 22, as seen inFIG. 1A. Various modular handle units and vessel harvesting systems areillustrated and described in aforementioned application Ser. No.10/951,426, filed Sep. 28, 2004.

In the particular embodiment of FIGS. 1A-1C, the handle sled 24 providesan adapter for multipurpose handle bases common to a number of vesselharvesting systems, such that a tissue welding and severing device 30 ofthe present invention may be used for vessel harvesting within thesystem. Specifically, the handle sled or adapter 24 provides a port 32leading to an internal angled channel 34 through which the elongatedshaft 36 of the welding and severing device 30 may extend. The handlebase 22 and handle sled 24 couple such that the elongated shaft 36 isguided through the distal flange 26 and harvesting cannula 28. The finalassembly as seen in FIG. 1C shows that some of the movement controls forthe harvesting tools are located on the handle unit 20, while rotationof the welding and severing device 30 is accomplished by manipulatingthe entire handle 38 relative to the sled 24 with a second hand.

FIG. 1C also illustrates an enlarged distal end of the cannula 28through which a distal end of the tissue severing/welding device 30projects. The device 30 comprises a pair of relatively movable elongatedjaws 40, 42 on its distal end, which are shown open. Preferably, amechanism within the handle 38 includes an actuator 44 for opening andclosing the jaws 40, 42. The jaws 40, 42 are elongated generally in aproximal-distal direction such that they are much longer in thatdirection than in either orthogonal or transverse axis.

It should be understood that the term “jaw” refers to a member that maybe brought together with another similar member or other structure suchthat jaw-facing surfaces on both members are brought into contact orclose proximity. A jaw may be provided on a clamp, tweezers, forceps, orsimilar grasping tools. The jaws 40, 42 are mounted such that theirproximal ends are journalled about common or different but closelyspaced pivots and their distal ends open and close. Of course, the jawsmay be mounted for parallel movement instead of in a pivoting action. Anexemplary embodiment of the present invention includes a “hot” jaw and a“cold” jaw, the difference being that only one jaw is actively heated.It should be emphasized, however, that certain aspects of the presentinvention are applicable to different jaw configurations, such as bothbeing “hot” jaws, or both being “cold” jaws with a separate source ofheat.

In a preferred embodiment, the first jaw 40 comprises a “hot” jaw, whilethe second jaw 42 is a “cold” jaw. The term “hot” refers to the presenceof at least one active heating element thereon, while a “cold” jawprovides no active heating (but may become hot from indirect heating bythe other jaw). In the illustrated embodiment, as seen in FIG. 1C, thefirst or “hot” jaw 40 includes a first heating element 46 for weldingtissue and a second heating element 48 for severing tissue. The firstheating element 46 is adapted to heat up to a first temperature uponapplication of current there through, while the second heating element48 is adapted to heat up to a second temperature upon application ofcurrent there through which is greater than the first temperature.Conventional understanding is that when vascular tissue is heated inexcess of 100° C., the tissue will be broken down and is thus, “cut”.However, when vascular tissue is heated to temperatures between 50 to90° C., the tissue will instead simply “seal” or “weld” to adjacenttissue.

Various means are described herein for ensuring that the first heatingelement 46 heats up to within a welding temperature zone but not to acutting temperature threshold, while the second heating element 48 heatsup past the welding temperature zone into the cutting temperature zone.For example, the relative electrical resistance values of the first andsecond heating elements 46, 48 may be such that they heat up todifferent temperatures. Alternatively, the materials used may be thesame, but the first and second heating elements 46, 48 may be shaped ina manner that causes their differential heating. Still further, thecurrent passed through the two heating elements may be unequal.

FIG. 1C also basically illustrates a preferred configuration of the jaws40, 42 and a distal end of the shaft 36 extending through a distal endof the elongated cannula 28. In particular, the jaws 40, 42 are arrangedto pivot apart about a common axis, represented by pivot pin 50. Anexemplary mechanism for opening and closing the jaws 40, 42 will bedescribed in detail below. Each of the jaws 40, 42 includes an inner jawmember of rigid material and a boot 52 a, 52 b (as seen in FIG. 3A)surrounding the inner jaw member that is made of the material thatresists tissue adhesions during operation of the device. In oneembodiment, the inner jaw members are made of stainless steel, but othermaterials that provide less of a heat sink may be used. Preferably, theboots 52 a, 52 b are made of a heat-resistant silicone rubber. The boots52 a, 52 b also provide some thermal insulation around the inner jawmembers to reduce heat losses thereto. The first and second heatingelements 46, 48 are arranged external to the boot 52 a on the first jaw40, in particular on a surface of the jaw that faces the other jaw.

FIGS. 2-7 provide a number of assembled, exploded, and other partialviews of the distal end of an exemplary tissue welding and severingdevice 30 of the present invention. In FIGS. 2A-2B, the jaws 40, 42 areshown closed at the distal end of the welding and severing device 30.The device 30 includes a generally tubular distal tip 54 that fits onthe end of the device shaft 36 and houses a mechanism (described below)for opening and closing the jaws 40, 42. Both jaws 40, 42 exhibit ashallow curvature along their lengths such that their jaw-facingsurfaces contact along a curved line. In a preferred embodiment, theentire distal assembly of the device 30 including the jaws 40, 42 issized to fit through a 5 mm diameter port, thus enabling use inminimally invasive surgery.

The jaws 40, 42 preferably incorporate a multiple heater welding systemon a “hot” jaw 40. At a minimum, at least two heating element areprovided, with one heating element adapted to sever tissue and a secondheating element adapted to weld or coagulate tissue. In an exemplaryembodiment, the jaw 40 incorporates a “tri-heater” arrangement with oneheating element for cutting and two heating elements for weldingdisposed on either side of the cutter. Desirably, the heating elementsextend longitudinally from a proximal to a distal end of the jaw 40,with the cutter generally centrally located and the two welderssymmetrically located on either side.

FIGS. 3A-3B illustrate the jaws 40, 42 in their open configuration. Ascan be seen in FIG. 3B, the first heating element 46 is preferablybifurcated into two welding members separated laterally, with a singlesecond heating element 48 provided there between. The bifurcated weldingmembers of the first heating element 46 each provide a weld regionwithin the tissue, while the second heating element 48 cuts the tissuewithin the weld region. Technically, therefore, the hot jaw 40 includesthree heating elements: a central cutting element and two adjacentwelding elements. Although the exemplary embodiment combines the twoadjacent welding elements in a single piece, they could easily beconstructed separately. As mentioned above, one or both jaws 40, 42include inner jaw members surrounded by a boot 52 a, 52 b. The boot 52 baround the second jaw 42 is preferably provided with a series of lateralserrations 60 that facilitate gripping and prevent slipping of thetissue when clamped between the jaws. Because of the presence of thefirst and second heating elements 46, 48 on the exterior of the boot 52a on the first jaw 40, no serrations are necessary.

FIG. 4 shows the components of the distal end of the device 30 exploded,while FIGS. 5-7 best illustrate the specific shapes and subassembly ofthe first and second heating elements 46, 48, and how they mount on andcooperate with the first jaw 40. The inner jaw member 62 (seen isolatedin FIGS. 8A-8H) of the first or “hot” jaw 40 comprises an elongated andcurved distal portion 64 and a proximal pivot housing 66, includingthrough holes for pivotal movement with respect to the other jaw. Morespecifically, the proximal pivot housing 66 of the inner jaw member 62includes a large circular through hole 67 and an angled slot 68, bothformed in an outer wall section 69. A pair of sidewalls 70 upstandingfrom the outer wall section 69 provide a space on the inner side of thepivot housing 66 within which electrical wires and a pivot mechanism arereceived, as explained below.

The first heating element 46 comprises a proximal crimp 72 and flange73. Two elongated welding members 74 extend from the proximal crimp andflange in a distal direction and curl back upon themselves to terminateat a common barb 75 (see FIG. 7B). The elongated welding members 74preferably comprise thin, rectangular strips each having a lateral widthW that extend in parallel across a spaced distance S. Because thewelding members 74 are connected at their proximal ends by the crimp 72and flange 73 structure, and at their distal ends by the common barb 75,they define a bifurcated portion of the first heating element 46. In apreferred embodiment, the first heating element 46 comprises a single,homogeneous piece of metal (e.g., stainless steel) that has been formedinto the illustrated shape by stamping, bending, machining, etc.

The second heating element 48 extends between and in parallel with thespaced welding members 74 and is separated therefrom by air gaps. Theheating element 48 also extends in a distal direction the same length asthe welding member 74 and curls back upon itself to terminate at aconnection end 76 adjacent the barb 75 (see FIG. 7B). The connection end76 and barb 75 are electrically connected using a resistance or spotweld, for example. In the context of the present application, the term“resistance weld” used to describe the joint between two mechanicalparts encompasses all suitable varieties of such joints, including forexample, spot welds, laser welds, soldered joints, brazed joints, etc.

As seen in the exploded view of FIG. 4, the heating element 48 maycomprise an elongated wire or rod, and the connection end 76 may beformed by a separate U-shaped coupling 77 forming a series extensionthereon. The second heating element 48 has a raised profile relative tothe first heating element 46 in a direction toward the second jaw 42.This enhances the differential ability of the second heating element 48to cut through tissue while the first heating element 46 welds.Furthermore, the strip-like welding members 74 of the first heatingelement 46 each have flat jaw-facing surfaces, while the second heatingelement 48 defines a cylindrical jaw-facing surface having a lateralwidth smaller than that of either welding member.

An exemplary first heating element 46 is seen isolated in FIGS. 9A-9E.These illustrations show a heating element 46 that is slightly differentthan the one shown in preceding figures, although either may be usedwith good results. The difference is in the distal end which exhibits aflange 78 that is bent, for example, at 90° instead of curling back intothe barb 75 toward the proximal end. The flange 78 is forked to define agenerally semi-circular opening 80 that receives the second heatingelement 48. Although not shown, in this version the second heatingelement 48 curls 180° into the opening 80 and is secured in electricalcontact therewith using a resistance weld, for example.

Now with specific reference to FIGS. 5-7, the heating elements 46, 48are shown having conductor wires attached thereto to form a seriescircuit. As seen in FIGS. 6B and 7A, a pair of insulated conductor wires82, 84 form part of a circuit path through the heating elements 46, 48.The first conductor wire 82 is in electrical communication with thefirst heating element 46 by virtue of a resistance weld at the proximalcrimp 72, while the second conductor wire 84 is in electricalcommunication with the second heating element 48. An insulated sleevearound the second conductor wire 84 extends through an aperture formedin the flange 73 of the first heating element 46. The barb 75 andconnection end 76 are electrically connected such that the first andsecond heating element 46, 48 define a current loop all along the lengthof the jaw 40.

Current through the conductors 82, 84 therefore passes in series throughthe first and second heating elements 46, 48. Current through the twoheating elements 46, 48 remains separated to the common distal endthereof, and in particular to the resistance weld between the barb 75and connection end 76. Because of the bifurcation of the first heatingelement 46 into the separate welding members 74, each of the weldingmembers 74 conducts in parallel approximately half of the current thatpasses through the second heating element 48. It should be understood,therefore, that if the heating elements are identical in shape andmaterial, each welding member 74 would heat up to a temperature lessthan that which the second heating element 48 attains because of thesplit current. This differential helps ensure that the first heatingelement 46 reaches the welding zone temperatures, while the secondheating element 48 reaches temperatures within the cutting zone. In theillustrated embodiment, the separate welding members 74 each have awider profile (i.e., larger surface area) facing the tissue in a planetransverse to the direction of elongation of the jaw 40 than does thesecond heating element 48. This structural difference in conjunctionwith the lower current and thus lower temperature helps facilitate awelding action on the tissue as opposed to a cutting action, in contrastto the central heating element 48 which is both narrower and hotter (andraised up higher).

Advantageously, however, the second heating element 48 is constructed soas to have a higher electrical resistance than either of the weldingmembers 74, and therefore even more of the already larger currentdissipates as heat. This combined phenomena of higher current and higherresistance causes the second heating element 48 to heat up to a cuttingtemperature zone, while the first heating of the 46 only reachestemperatures in the tissue welding zone. In a preferred embodiment, thefirst heating element 46 is made of a suitable conductive metal such as301 stainless steel, while the second heating element 48 comprises atube of rigid material with filler having a higher magnitude ofelectrical resistance than the tube, the combination having anelectrical resistance greater than stainless steel. In one specificembodiment, the tube is made of a nickel-chromium alloy such as INCONEL625 and is filled with an electrically insulating but thermallyconductive ceramic such as magnesium oxide (MgO) powder. Consequently, agreater current density passes through the hollow tube than if it weresolid, and therefore the material reaches a higher temperature at anygiven current. Additionally, the inner thermally conductive ceramic doesnot unduly restrict conductive heat flow through the element 48.Preferably, the second heating element 48 has a relatively highresistance of about 0.2 Ohms, and the entire system of the first andsecond heating elements has an average resistance of about 0.72 Ohms,and preferably less than 0.8 Ohms.

It is important to understand that the present invention contemplates atleast one cutting element and at least one welding element, electricallyconnected in series or not. For example, the illustrated embodiment maybe modified by utilizing two current paths, one for the first (welding)heating element 46 and one for the second (cutting) heating element 48.Alternatively, one cutting element and a single (i.e., not bifurcated)welding element may be provided on the hot jaw, both forming a part of acommon current path. Finally, the same arrangement can be utilized withseparate current paths. Moreover, as mentioned above, the cuttingelement may be provided on one jaw while the welding element is providedon the opposite jaw. In each of these alternative configurations, thecommon denominator is that upon application of a common or separatecurrents, the cutting element reaches a higher temperature than thewelding element.

FIGS. 10A-10H show a number of views of an exemplary boot 52 a used onthe “hot” jaw 40. As mentioned above, the boot 52 a is made of materialsuch as silicone rubber that resists tissue adhesions, and thusfacilitates multiple tissue severing/welding operations prior to areduction in the effectiveness of the jaws because of such tissueadhesions. The boot 52 a provides electrical insulation between theheating elements 46, 48, and also provides thermal insulation, thushelping to retain heat to the space between the jaws as opposed to beinglost to the often metallic inner jaws 62. The boot 52 a generallycomprises a hollow sleeve having an open proximal end 86 and a partiallyclosed distal end 88. An upper surface 90 that faces the cold jaw 40when the boot 52 a is mounted on the hot jaw 40 includes a pair oflongitudinally-oriented rails 92. As seen in FIGS. 10D and 10G, therails 92 are generally evenly spaced apart and provide guide channelsfor the bifurcated first heating element 46 and the central secondheating element 48. The distal end 88 of the boot 52 a has an openinginto which extend the joined and curled or bent distal ends of the twoheating elements 46, 48. This holds the distal ends of the twoelectrodes on the hot jaw 40. It should be noted that the distal end ofthe inner jaw member 62 has a forked depression as seen at 93 in FIG.7C. The insulating boot 52 a is molded so that it has an inside shapewhich conforms within this depression 93, and also provides an outwardlyopening cavity to receive the joined barb 75 and connection end 76. Thearrowhead shape of the barb 75 helps secure the heating elements inplace with respect to the soft insulating boot 52 a, which, again, ispreferably silicone rubber.

FIGS. 5-6 illustrate the integration of the combined heating elements46, 48 and conductor wires 82, 84 into the inner jaw member 62. As seenbest in FIG. 6B, the proximal crimp 72 secures the first heating element46 and an extension of the silicone boot 52 a to an upstanding flange 94of the pivot housing 66. The conductor wires 82, 84 are routed throughthe space in the pivot housing 66 formed by the pair of sidewalls 70.The first conductor wire 82 extends straight along one side wall 70 andis resistance welded or otherwise secured to the proximal crimp 72 ofthe first heating element 46. The second conductor wire 84 follows abent path along the other side wall 70 and passes through theaforementioned aperture formed in the proximal flange 73 of the firstheating element 46, as seen in FIG. 6A. FIG. 5B shows a bushing 96having an upstanding shaft stub 98 assembled over the pivot housing 66.The bushing 96 forms a part of a mechanism for opening and closing thejaws 40, 42, and will be more clearly described below.

One aspect of the present invention that facilitates assembly and thusreduces fabrication cost, is the integrated nature of the heatingelement subsystem. The subsystem is seen in FIGS. 6B and 7A, andconsists of five parts: the first heating element 46, the second heatingelement 48, the pivot housing 66 (typically fabricated integral with thefirst inner jaw 62), and the two wires 82 and 84 that provide currentthrough the series heating elements. These five parts are held togetherwith several crimps, or desirably resistance welds, or both, and may beeasily assembled prior to integration with the rest of the hot jaw 40.

As mentioned above, either or both of the jaws 40, 42 includes an innerjaw member covered with a boot. The exploded view of FIG. 4 shows boththe inner jaw member 62 of the hot jaw 40, and an inner jaw member 102of the second or “cold” jaw 42, along with the associated boots 52 a, 52b. Both boots 52 a, 52 b fit over and surround the curved distalportions of the inner jaw members 62, 102, respectively.

In prior tissue welders, stainless steel inner jaw members wereconveniently used as the return conduction path for the current passingthrough one or more electrodes. This had a distinct disadvantage in thatsome of the current was dissipated as resistance heat generated withinthe inner jaw member. This also had a disadvantage of heat conductionfrom heating element into jaw that resulted in less efficient energydelivery to tissue and potential inadvertent thermal injury. In oneaspect the present invention not only physically decouples the heatingelements 46, 48 from the first inner jaw member 62, in that a layer ofthe insulating boot 52 a is interposed there between, but no currentruns through the inner jaw member. The series connection between thedistal barb 75 and connection end 76 means that the entire electricalconduction path along the hot jaw runs only through the heating elements46, 48. In this way, the efficiency of conversion of electrical energyinto desirable resistance heat is maximized, and the footprint of thedevice on tissue other than that directly in contact with the heatingelements is minimized.

In addition to being able to weld and sever tissue, and in particularblood vessels, the jaws 40, 42 may also be capable of performingfasciotomy, or an incision through fascia (e.g., bands or fillets offibrous tissue that separate different layers of tissue). As seen bestin FIG. 3B, where the jaws 40, 42 are shown open, the second heatingelement 48, the “cutter wire,” extends the full-length of the jaw alongits midplane. In addition, it is positioned so as to be raised upwardfrom the surrounding weld members of the first heating element 46 andthus presents the first surface of the hot jaw 40 to contact tissuereceived within the jaws. Fasciotomy can be performed by merely pushingthe open jaws through a band of tissue with the second heating element48 energized such that it cuts the tissue by heating it above thecutting temperature. Of course, in the exemplary embodiment the firstheating element 46 also heats up, although this will have negligibleimpact on the fasciotomy procedure.

FIG. 4 also illustrates a tapered tip 103 on the distal end of the innerjaw member 102 of the second or “cold” jaw 42. This tip 103 helpsfacilitate blunt dissection of tissue when the device is used as such.The surrounding boot 52 b will have a similar taper. In a preferredembodiment, the inner jaw member 102 has a generally rectangularcross-section, and the tip 103 has two tapers provided on the oppositestraight sides. Of course, other arrangements such as a more roundedcross-section and a conically-tapered tip 103 may be substituted.Moreover, the inner jaw member 102 of the cold jaw 42 is slightly longerthan the more blunt inner jaw member 62 of the first jaw 40 to furtherease dissection of tissue.

Attachment of the jaws 40, 42 to the distal end of the tissue weldershaft 36, and an exemplary mechanism for opening and closing the jawswill now be described.

With reference to the exploded view of FIG. 4, and also to FIGS. 3 and5, the pivot housing 66 of the first inner jaw member 62 comes togetherwith a proximal pivot housing 104 of the second inner jaw member 102,capturing the bushing 96 there between. The bushing 96 includesoppositely directed shaft stubs 98 that fit within the aligned aperturesformed in the pivot housings 66, 104, such as the aperture 67 seen inFIG. 6B. The bushing 96 includes features on one side that mate with theparticular shape of the pivot housing 66 and conductor wires 82, 84arranged therein. In this regard, the bushing 96 is fixed with respectto the pivot housing 66 of the first inner jaw member 62. The pivothousing 104 of the second inner jaw member 102, on the other hand,includes a flat lower surface that slides across a flat upper surface ofthe bushing 96 when the housing pivots about the shaft stub 98.Consequently, the first inner jaw member 62 and second inner jaw member102 are permitted to pivot with respect one another about the shaftstubs of the bushing 96.

The exploded view of FIG. 4 also shows the distal end of the flexibleshaft 36 which includes a stepped-down portion 110. The flexible shaft36 is hollow and receives a control rod 112 there through. A generallyY-shaped yolk 114 attaches to the distal end of control rod 112 througha resistance weld or similar expedient (not shown). Linear movement ofthe control rod 112 therefore also moves the yolk 114. The generallytubular shaft tip 54 fits over the stepped-down portion 110 and issecured thereto with a rivet 118.

With reference primarily to FIG. 4, but also FIGS. 2 and 3, the tubularshaft tip 54 includes a bifurcated distal end having a pair of arms 120defining side openings 122 there between. As will be explained, thepivot housings 66, 104 of the jaws extend between the arms 120 and theside openings 122 permit pivotal movement thereof. The assembly of thetwo pivot housings 66, 104 with the bushing 96 there between issandwiched between a pair of small spacers 124 that have flat innersurfaces and partial cylindrical outer surfaces. The spacers 124 includethrough bores that align with the apertures 67 in the pivot housings andwith the inserted shaft stubs 98. The jaw assembly including spacers 124then fits between the bifurcated arms 120 and is secured therein with arivet 126 that passes through a pair of apertures 128 in the fingers,and through the aforementioned apertures. The jaws 40, 42 thereforepivot about the shaft stubs 98.

Both of the pivot housings 66, 104 include the angled slots 68 that aregenerally aligned with elongated slots 130 formed in both of the arms120 of the shaft tip 54. As seen in the exploded view of FIG. 4, theangled slots 68 are oppositely oriented with respect to one another. Thecombined thickness of the assembled pivot housings 66, 104 fits betweenthe bifurcated fingers of the yolk 114 and a rivet 132 passes throughapertures in the distal ends of the yolk fingers and through the angledslots 68. In this way, linear movement of the yolk 114 translates intolinear movement of the rivet 132, which in turn opens and closes thejaws 40, 42 through a camming action in the angled slots 68. Theelongated slots 130 provide clearance for the rivet heads, ensure planaralignment of the rivets, and also facilitate assembly thereof. With theangled slots 68 oriented as shown, the jaws will be open when thecontrol rod 112 is displaced distally, while proximal movement of thecontrol rod closes the jaws.

Electricity can be delivered to the jaws 40, 42 through the conductorwires 82 and 84, best shown in FIG. 6B, or directly through the pivotingmechanism just described. For example, the control rod 112 may beelectrically conductive and provide current to the inner jaw members and62, 102 via the connecting the yolk, pins, and angled slots. The returncurrent path might be provided by a single conductive wire. Theillustrated embodiment utilizing conductor wires 82, 84 is preferredbecause it eliminates moving parts from the electrical conduction path.

Within the constraints of the small diameter design (less than 5 mm),the jaw movement mechanism should be relatively robust to be capable ofapplying a closing force of around 1-3 lb, preferably about 1 lb, and anopening force of around 1-3 lb. Further, the jaw opening distance at thedistal tips thereof is desirably about 8 mm. In addition to welding andcutting tissue, the jaws can also be used for blunt dissection becauseof the tapered and rounded outer shape of the jaws. This bluntdissection can also be enhanced by the relatively robust opening forceprovided by the jaws.

As will be apparent, the jaw opening and closing function can beachieved in many different ways. The present invention, in its broadinterpretation, is not particularly limited to any one type ofmechanism. For example, instead of both jaws pivoting about a commonaxis, a series of linkage members may be utilized with the jaws pivotingabout spaced axes. The form of jaw opening apparatus is preferablychosen to minimize cost and optimize transfer of linear force topivoting movement of the jaws. Optionally, the pivoting mechanism isconfigured such that the jaw-facing surfaces of the jaws remainparallel.

An exemplary control handle 38 seen in FIGS. 11A-11C and 12 contains amechanism for actuating the control rod 112 and opening and closing thejaws, in addition to several other desirable features. The controlhandle 38 is seen in elevation and two opposite partial sectional viewsin FIGS. 11A-11C. The control handle 38 includes an outer housing 140formed by the juxtaposition of two molded housing halves 140 a, 140 b.The outer housing 140 includes a plurality of walls and/or bulkheads 141that defined there between a series of internal housing cavities. Adistal through bore formed in the outer housing receives the flexibleshaft 36 leading to the distal jaws 40, 42. The aforementioned actuator44, in the illustrated example, is journalled to pivot about a pin 142fixed with respect to the housing, and includes a thumb pad 144 oppositethe pin 142. A narrow section of the actuator 44 travels within aproximal-distal slot 146 in the housing 140 such that the thumb pad 144provides a slider for the user. The actuator 44 is therefore constrainedto pivot in a hollow space between the two housing halves 140 a, 140 band the thumb pad 144 travels between opposite ends of the slot 146.Movement of the slider 144 in a distal direction (to the left in FIG.11A) closes the jaws, while movement of the slider in the proximaldirection (to the right in FIG. 11A) opens the jaws.

The exemplary control handle 38 includes circuitry for energizing theaforementioned heating elements at the distal end of the tool inaddition to the mechanism for opening and closing the jaws. Although theinvention is not limited to one particular switching arrangement, theexemplary embodiment includes a weld/cut switch that actuates both thewelding heating element and the cutting heating element simultaneously,and coincident with the jaw closed position. Moreover, the controlhandle 38 includes a governor for limiting the force that can be appliedby the jaws on tissue held there between.

With reference still to FIGS. 11A-11C, and in particular the explodedview of FIG. 12, the actuator 44 possesses an enlarged mid-section 150having a vertically elongated proximal-distal through bore 152 definedtherewithin. The through bore 152 receives therein a rod 154 having aproximal head 156 and a distal head 158. The proximal end of the rod 154extends through a force transfer block 160 and into a cavity to theproximal side of the actuator 44. The force transfer block 160translates in a proximal-distal direction between a pair of guide walls162 formed in the housing and includes a bore that slides over the rod154. A force-limiting spring 164 closely surrounds the rod and isconstrained between the proximal head 156 and the force transfer block160. The distal end of the rod 154 extends to the distal side of theactuator 44 such that the distal head 158 is captured within a forcecoupler 166. FIG. 12 illustrates best the internal contours of thegenerally box-shaped force coupler 166 which includes a large cavity, asmaller cavity in which the distal head 158 is received, and a pair ofslots on opposite ends thereof (elements not numbered for clarity). Oneside of the force coupler 166 is removed to facilitate assembly of thecooperating parts, as seen in FIG. 11C. Like the force transfer block160, the force coupler 166 translates in a proximal-distal directionbetween a pair of guide walls 174 formed in the housing.

With specific reference to FIG. 11B, a small tang 180 projects laterallyfrom the enlarged mid-section 150 of the actuator 44. The tang 180 ispositioned to engage and trip a weld/cut switch 182 mounted within thehousing 140. That is, the switch 182 is fixed with the respect to thehousing 140, while the tang 180 pivots with the actuator 44. When thethumb pad 144 translates in a proximal direction within the slot 146,the actuator 44 pivots in a clockwise direction until the tang 180actuates the lever of the weld/cut switch 182. An electrical wire 184extends into the proximal end of the handle 38 and provides power to theswitch 182. From there, an electrical lead 186 continues in the distaldirection and passes through the flexible shaft 36 to the heatingelements on the jaws at the distal end of the tool.

FIGS. 11 B and 11C illustrate a cylindrical filter 190 captured betweenbulkheads 141 at the distal end of the housing 140. The generallytubular filter 190 is seen exploded in FIG. 12, and includes a steppedthrough bore 192 that receives, on either end, a pair of O-rings 194.The O-rings 194 each have an inner diameter that closely fits and sealsaround the flexible shaft 36. The shaft 36 extends into the distal endof the housing 140, through the filter 190, and terminates at a seal 196adjacent one of the bulkheads 141 of the housing. As shown in FIG. 11C,the control rod 112 continues through the seal 196 and into the forcecoupler 166. A collar 200 received in the large cavity of the forcecoupler 166 fastens to the proximal end of the control rod 112 with aset screw 202. In this manner, the proximal end of the control rod 112is constrained by the collar 200 within the force coupler 166.

In use, the operator slides the thumb pad 144 in a distal directionalong the slot 146 as seen by arrow 204 in FIG. 11C to pivot theactuator 44 and open the jaws of the tool. As the actuator 44 pivots,its angular movement is accommodated by the elongated through bore 152over the rod 154. A curved distal face of the enlarged mid-section 150eventually contacts the proximal end of the force coupler 166 and actsas a cam to urge it in a distal direction. Because the collar 200 isconstrained within the larger cavity of the force coupler 166, it alsotranslates in a distal direction which, in turn, pushes the control rod112 distally. In this embodiment, there is no clutch or force-limiterinterposed between the actuator 44 and distal movement of the controlrod 112 to open the jaws. Therefore, the extent that the jaws open islimited by the extent of travel of the thumb pad 144, or by the hingemechanism of the jaws themselves.

Conversely, the operator slides the thumb pad 144 in a proximaldirection along the slot 146 as seen by arrow 206 in FIG. 11B to pivotthe actuator 44 and close the jaws of the tool. A curved proximal faceof the enlarged mid-section 150 eventually contacts the distal end ofthe force transfer block 160 and acts as a cam to urge it in a proximaldirection. Because the force transfer block 160 is free to slide overthe rod 154, it moves in a proximal direction toward and compresses thespring 164. Compression of the force-limiting spring 164 applies aproximally-directed force to the proximal head 156 of the rod 154.Because the distal head 158 is constrained within the stepped cavity ofthe force coupler 166, which in turn is connected to the control rod112, the resistance to proximal displacement of the rod 154 is providedby any force resisting closure of the jaws (assuming minimal frictionalforces acting on the control rod 112). Prior to the jaws clamping anytissue, this resistance to proximal displacement of the rod 154 isminimal and proximal displacement of the force transfer block 160translates into equivalent displacement of the control rod 112. However,when the jaws finally close on tissue, the maximum closing force of thejaws is limited by the stiffness of the spring 164. Specifically, afterthe jaws close a constant force is applied to the tissue there betweenbecause of the spring 164.

Through careful calibration of the force-limiting spring 164 inconjunction with the particular jaws on the tool, this closing force canbe limited to less than that which would unduly crush or otherwise causetrauma to the tissue within the jaws. Those of skill in the art willunderstand that it is the pressure applied to the tissue that must belimited, and that the pressure partly depends on the shape and size ofthe jaws, as well as the elastic constant of the spring 164. Desirably,the force imparted on tissue by the jaws is between about 1-3 lbs.(0.45-1.36 kg), and preferably about 1 lb, as regulated by the spring164. This preferred range of force ensures the heating elementseffectively weld and sever tissue held within the facing surfaces of thejaws in a reasonably short amount time, preferably within 5 seconds orless. That is, applying a force of less than 1 lb to tissue tends todelay the cutting function, while application of a force greater than 3lbs. tends to sever the tissue before an effective weld is formed.Again, this preferred force range and operation time to depend upon thesize and shape of the jaws. However, given the constraints of endoscopictissue welding, in particular during vessel harvesting procedures, theseparameters are believed to encompass a wide range of suitable jaw types.

To better explained the desirable weld parameters of the tissue welder,the reader is directed back to FIGS. 8A-8H showing the inner jaw member62 of the hot jaw, and FIGS. 10A-10H showing the boot 52 a that coversthe inner jaw member 62. The inner jaw member 62 has the curved distalportion 64 extending from the proximal pivot housing 66, and a lengthfrom the circular pivot hole 67 to its distal tip of approximately 0.740inches (18.80 mm). As mentioned above, the inner jaw member 102 of thecold jaw 42 is slightly longer than the more blunt inner jaw member 62of the first jaw 40 to ease dissection of tissue, and preferably has alength of approximately 0.765 inches (19.43 mm). Desirably, the jawmember 62 is made of stainless steel, although other materials,thermally conductive or otherwise, may be utilized. The transversecross-sectional shape of the distal portion 64 is approximately squareadjacent the pivot housing 66, having a dimension on each side ofapproximately 0.060 inches (1.52 mm).

The dimension of the tissue-facing side of the distal portion 64, seenin FIG. 8E, remains constant along the length of the jaw member 62,while the perpendicular dimension seen in FIGS. 8D and 8F graduallytapers smaller toward the distal tip to a final dimension of about 0.031inches (0.79 mm). The boot 52 a seen in FIGS. 10A-10H has an overalllength sufficient to cover the curved distal portion 64, and atransverse tissue-facing width of approximately 0.082 inches (2.083 mm).The dimensional parameters of the boot 52 b of the cold jaw areequivalent, although the two boots perform different functions and arethus configured differently.

The previously mentioned desirable clamping force of the jaws of between1-3 pounds can also be characterized in terms of pressure on the tissueto produce the most effective balance between severing and welding.Using the approximate dimensional values given above, the jaws desirablyexert a pressure on the tissue of between about 25-75 psi, averagedtransversely across the tissue-facing surfaces of the boots 52 a, 52 b.It should be understood that this range is an estimate based on thenon-uniform contours of the tissue-facing surfaces of the boots 52 a, 52b, and those of skill in the art will understand that structuralmodifications to the jaws may affect the preferred force and/or pressurerange. Moreover, the temperature to which the heating elements on thejaws rise also affects the preferred force applied, as well as theduration of the weld. Once again, a commonly accepted range oftemperatures at which human tissue may be welded is 50 to 90° C., whilesevering occurs at temperatures of 100° C. and above. Using theseguidelines, if the exemplary jaws apply a clamping force of between 1-3pounds on tissue and the welding and severing heating elements areenergized to these temperatures, a preferred duration of weld is between1-5 seconds. If the clamp duration is too short, the weld may not beeffective and the tissue is less likely to completely sever, while anexcessive duration above 5 seconds may tend to char tissue.

Still with reference to FIG. 11 B, movement of the actuator 44 in thedirection of arrow 206 also displaces the tang 180 into engagement withthe weld/cut switch 182. Even if the intervening force-limiting spring164 limits further closure of the jaws, the actuator 44 can continuemovement until the switch 182 is tripped. The control handle 38 of thepresent invention further includes feedback to indicate to the useraurally and via tactile sensation through the thumb pad 144 when theswitch 182 has been tripped, both on and off. More particularly, FIGS.11C and 12 illustrate a small protrusion 208 projecting laterally fromthe actuator 44. This protrusion pivots along with the actuator andengages a small tooth 210 provided on a pivoting detent lever 212 (seeFIG. 12). Although not shown in FIG. 11C, the detent 212 pivots about apoint fixed within the housing 140 and the tooth 210 is biased upward bya detent spring 214. The protrusion 208 cams past the tooth 210 whichdisplaces and provides both an audible and tactile click to the user atthe point that the switch 182 is tripped ON. Movement of the actuator 44in the opposite direction also causes the protrusion 208 to cam past thetooth 210, thus indicating when the switch 182 is turned OFF. In anexemplary procedure, the weld time is typically less than 5 seconds.

The exemplary control handle 38 illustrated in FIGS. 11A-11C and FIG. 12further includes a system for capturing smoke or particulate matter thatis generated by the distal jaws at the operating site within the tissuecavity. As mentioned above, various end effectors may be utilized withcertain aspects of the present invention, with resistance heatingelements being featured as the exemplary embodiment. Most of these endeffectors, including resistance heating elements, often cause asubstantial amount of smoke to be generated from the heated tissue.Furthermore, the operation is typically performed using CO.sub.2insufflation which creates a pressure gradient forcing gas in a proximaldirection through the flexible shaft 36.

To control egress of this smoke through the flexible shaft 36, thecontrol handle 38 provides the aforementioned passive filter 190. Theflexible shaft 36 includes at least one gas escape port 220 at itsproximal end. This port 220 is positioned between the O-rings 194 andwithin the hollow interior of the filter 190. The hollow cavity withinthe filter 190 provides a venting chamber or space to receive the gassesfrom the port 220. In addition, the proximal end of the flexible shaft36 is capped by the seal 196 which conforms closely around the controlrod 112 and electrical lead 186. All of these seals force any gas (andsmoke or particulate matter) traveling proximally through the flexibleshaft 36 to exit through the gas escape port 220. Consequently, the gasis forced through the gas permeable material of the filter 190 whichtraps any smoke or particulate matter before it reaches the interior ofthe housing 140. From there, the now filtered gas, predominantlyCO.sub.2, passes through the various cavities within the housing 140 andexits through random fissures and openings therein.

Several alternative configurations for filtering smoke generated by thetissue welding procedure are seen in FIGS. 11D-11F. First of all, FIG.11 D illustrates the exemplary control handle 38 having a small exhaustfan 222 mounted near its proximal end. The exhaust fan 222 helps pullgas passing through the elongated shaft 36 through the aforementionedpassive filter 190. In many instances means for gas insufflation isprovided in the overall system within which the tissue welders is used,which provides a positive pressure within the body cavity and forces gasproximally through the elongated shaft 36. However, in some procedureseither no insufflation is used or it does not generate sufficientpressure, in which case the auxiliary fan 222 helps pull the gas throughthe filter 190.

FIG. 11 E illustrates the interior of an alternative control handle inwhich a cooling apparatus 224, such as a Peltier cooler, is mountedadjacent the gas escape ports 220 in the elongated shaft 36. The smokeemitted from the port 220 connect is on the cooling apparatus 224, whicheffectively passively filters the gas which is then permitted to exitfrom various openings in the handle.

Alternatively, FIG. 11 F illustrates a further alternative controlhandle in which a plurality of louvers or fins 226 are arranged adjacentthe gas escape ports 220. The fins 226 diffuse and condense the smoketraveling proximally through the elongated shaft 36, and thus act as apassive filter. The gas is then permitted to exit from various openingsin the handle. Because the surface area through which the smoke exhaustsis expanded, the density of that smoke is decreased making it lessnoticeable as it exits the handle. In the illustrated embodiment, thefins 226 are configured as a series of concentric annular elements, butother arrangements are possible.

FIGS. 13A-13C illustrate an alternative control handle 38′ similar tothat described above but including a separate electrical circuit for afasciotomy cutter provided on a distal tool. As mentioned above,fasciotomy comprises an incision through fascia (e.g., bands or filletsof fibrous tissue that separate different layers of tissue). The tissuewelding/cutting jaws may also be adapted to include such a fasciotomycutter which enables the tool to be moved linearly through to cut tissuewithout opening and closing the jaws. The fasciotomy cutter may be aseparate heating element provided on the forward end of one of the jaws,or within the jaws. Some of the elements illustrated for the alternativecontrol handle 38′ are common to the control handle 30 described abovewith respect to FIGS. 11-12, and therefore will be given the sameelement number with a prime “′” designation.

As seen in FIGS. 13B-13C, the flexible shaft 36′ from the distal toolenters the molded housing 140′, and a control rod 112′ projectstherefrom into a cavity formed within the housing and is fixed to anenlarged collar 230. Although not shown, a shaft member 232 fastened tothe collar 230 extends in a proximal direction through a fasciotomyspring 234, and through an actuator 44′ to terminate at a proximal head236. The actuator 44′ is much like the actuator 44 described above, witha body that pivots about a pin 238 and has an elongated through bore forpassage of the shaft 232. The distal end of the shaft 232 having thecollar 230 thereon translates within a proximal-distal cavity 240, whilethe proximal end of the shaft having a proximal head 236 translateswithin a proximal-distal cavity 242. Because the control rod 112′ isrigidly fastened to the collar 230 which in turn is fastened to theshaft 232, movement of the shaft produces identical movement of thecontrol rod.

With particular reference to FIG. 13C, an annular cam follower 244surrounds the shaft 232 between the actuator 44′ and the fasciotomyspring 234. The cam follower 244 includes a short slot (not numbered)within which extends a small pin 246 projecting laterally from the shaft232. In the position illustrated, the actuator 44′ is in a neutralposition not in contact with the cam follower 244, which in turn istherefore biased in a proximal direction by the fasciotomy spring 234 asfar as the pin 246 and slot permit. A second cam follower 250 surroundsthe shaft 232 between the actuator 44′ and the fasciotomy spring 234. Aforce-limiting spring 252 is concentrically constrained around the shaft232 between the proximal head 236 and the second cam follower 250. Asnoted, the actuator 44′ is in the neutral position out of contact withthe second cam follower 250, and thus the force-limiting spring 252remains uncompressed.

A user displaces the thumb pad of the actuator 44′ in a proximaldirection as indicated by arrow 260 in FIG. 13B, which pivots theactuator 44′ and urges the cam follower 244 in a proximal direction.Compression of the fasciotomy spring 234 causes proportionaldisplacement of the collar 230 and control rod 112′, therefore openingthe jaws of the tool. At a certain distance of travel, the collar 230reaches the end of the cavity 240 and further movement of the controlrod 112′ is impeded, corresponding to the maximum opening distance ofthe jaws. However, because the cam follower 244 includes the linear slotin which the pin 246 travels, the actuator 44′ can continue its movementforcing the cam follower 244 proximally against the compressive force ofthe spring 234. The user experiences a resistance to movement of theactuator 44′ during this stage, which is an indication that thefasciotomy heater is activated. In particular, a tang 262 (FIG. 13C) onthe actuator 44′ eventually engages a fasciotomy switch 264 at the pointthat the fasciotomy spring 234 is being compressed. Although thecircuitry is not shown, the switch 264 is supplied with current and whenswitched ON provides current to leads extending through the flexibleshaft 36′ to the distal end of tool and fasciotomy heating element.

Conversely, the user displaces the actuator 44′ in a proximal directionas indicated by arrow 270 in FIG. 13C to close the jaws. A proximal faceof the actuator 44′ cams against the follower 250, which in turn actsagainst the force-limiting spring 252. As in the earlier embodiment, aminimal reaction force exists prior to the jaws closing and thusmovement of the actuator 44′ causes proportional movement of the controlrod 112′. At the point that the jaws close over tissue, theforce-limiting spring 252 determines the amount of pressure that may beapplied to the tissue before further movement of the actuator 44′ merelycompresses the spring without moving the control rod 112′. Near thelimit of travel of the actuator 44′ in the direction of arrow 270, thetang 262 engages a weld/cut switch 272 mounted within the housing 140′,thus actuating the welding and cutting heating elements at the distalend of the tool. The alternative control handle 38′ further includes adetent 274 that acts in the same manner as the detent 212 describedabove and indicates to the user when the weld/cut function is ON andOFF.

FIGS. 14A-14C illustrate a preferred linkage 300 between a control rodand the jaws for opening and closing the jaws. In the jaw openingmechanisms of the prior art, certain disadvantages were recognized thatincrease the overall size of the jaw assembly, increase the cost ofconstruction, exposed electrical connections to wear, or sacrificedmechanical and electrical consistency by including excess sources offriction, and sacrificed electrical consistency by relying on movingmechanical connections for electrical continuity, for example. Theexemplary linkage 300 and the associated “hard-wired” electricalconnection reduces the overall size of the jaws assembly, reduces thenumber of components and associated cost and complexity, improves therobustness of the mechanics, and improves the mechanical and electricalreliability (i.e., consistency) of the device.

A pair of jaws 302, 304 are shown open in FIGS. 14A and 14B. Each jawincludes a through bore that is journalled about a shaft 306, such asthe shaft stub 98 as seen in FIG. 5B. In this manner, proximal housings308, 310 of the respective jaws pivot with respect to one another. Anangled slot 312, 314 is provided in each pivot housings 308, 310. Anactuating pin 316 extends into both of the angled slot 3 12, 314 and isconnected to a proximal control rod (not shown). FIG. 14B illustratesthe distal end of a tool shaft 320 that encompasses the pivot housings308, 310. The tool shaft 320 includes a linear slot 322 within which theactuating pin 316 translates. The distal end of the tool shaft 320 shownis analogous to the shaft tip 54 seen in FIGS. 2 and 4.

FIG. 14C shows movement of the actuating pin 316 to the left whichcauses the jaws 302, 304 to close. That is, the pin 316 cams the angledslots 312, 314 such that their proximal ends come together as seen. Ofcourse, the reverse movement of the actuating pin 316 causes the jaws toopen again. Because of the simplicity of the mechanism, the overall sizeof the jaw assembly can be reduced so that it fits through a 5 mm insidediameter tube. Furthermore, the reduction in the number of parts obtainsan equivalent reduced manufacturing time and complexity, for a lowermanufacturing cost. The moving parts consist of the actuating pin 316translating within the three slots, and the two jaws which pivot withrespect one another. This reduces the sources of friction and thusimproves mechanical reliability. Finally, the angle of the slots 312,314 may be adjusted to change the actuation force required to open andclose the jaws.

That is, a shallower angle would necessitate a lower force from thecontrol rod to actuate the jaws. The trade-off, of course is that theopening distance of the jaws is concurrently reduced.

Clearly, the dual- or tri-heating element function can be achieved inmany different ways. The present invention broadly includes a heatingelement for cutting tissue and a heating element for welding tissue, andis not particularly limited to any one type of either apparatus.Examples include, but are not limited to two, three, or more heatingelements, cutting and welding heating elements separately activated orconnected in series or parallel, or both, heating elements on one orboth jaws, etc. The form of the multiple heating elements is preferablychosen so that they are relatively close together and one reliably cutsand the other reliably welds a variety of tissue.

Optionally, the multiple heating elements are configured such that theyoperate substantially simultaneously and ensure good hemostasis of thewelded tissue. The power applied and shape of the heating elements arechosen to ensure that inadvertent tissue charring or other such damagedoes not occur inadvertently during normal operation of the device. Theprimary clinical benefits of the heating elements of the presentinvention include but are not limited to balance of power outputs fromcutter and welder(s) for consistently strong welds, as well as thermalefficiency for faster weld times.

It should be understood that the force-limiting function of the springwithin the control handle can be achieved in many different ways. Thepresent invention, in its broad interpretation, is not particularlylimited to any one type of mechanism for limiting the closing force ofthe jaws, but is characterized by a force-limiting interface between thecontrol actuator and the elongated jaws for limiting the magnitude ofclosing force of the jaws. Examples include, but are not limited to theaforementioned spring provided within the control handle, a similarspring provided distal to the control handle, a pressure transducer onthe jaws which provides feedback to the user or other device forlimiting the force applied by the jaws, compliant jaws, etc. The form ofthe force-limiting apparatus is preferably chosen to limit the pressureapplied to tissue by the particular jaws. Optionally, the force-limitingapparatus is configured simply in a cost-effective manner. Theforce-limiting apparatus is chosen to ensure that crushing of tissuedoes not occur inadvertently during normal operation of the device.

Furthermore, aside from limiting the magnitude of force applied by thejaws, the present application contemplates applying force on the tissuewithin the jaws that is greater than a minimum but less than the forcethat would unduly damage the tissue. The minimum amount of force isdetermined such that an effective weld is created by clamping andheating the tissue. Accordingly, the minimum amount of force requireddepends on several factors, including the amount and duration of heatapplied, the size and shape of the jaws, the jaw and boot material, thesize and character of the tissue or vessel within the jaws, etc. In apreferred embodiment, a force-limiting mechanism interposed between thecontrol actuator and the jaws is adapted to regulate the magnitude ofclosing force of the jaws to a value calibrated to ensure the heatingelement effectively welds tissue held within the facing surfaces of theelongated jaws.

While the tissue welding system described thus far is believed to beparticularly effective, the present invention also provides a number ofalternative jaws and clamping mechanisms which are each believed to bepatentable in their own right. A number of these alternatives will nowbe described briefly with reference to FIGS. 15-48.

For example, the present application provides a number of embodimentsfor regulating the localized force applied to the tissue within thejaws. Several embodiments act to maintain parallelism of the jaws, whichhelps make the applied force, and thus applied heat, uniform from aproximal to a distal end of the jaws. Another configuration controls thegross movement of the jaws with respect one another such that theybehave in a non-linear fashion relative to movement of a handleactuator. In short, the present application provides numerousconfigurations for controlling the applied force and displacement of thedistal tissue welding jaws. It should be understood by the reader thatunless they are mutually exclusive, any of these jaw or clampingconfigurations can be coupled with any of the aforementioned controlhandle/shaft embodiments. For example, if a particular jaw includes amalleable tissue contacting surface, it may also be used with thecontrol handle 38 of FIGS. 11-12 which includes a pressure-limitingspring.

With reference now to FIGS. 15A-15B, a first embodiment of aforce-limiting structure within a control handle 350 is shown. Only aportion of the control handle 350 is illustrated, and the remainder ofthe control handle may be similar to that described with respect toFIGS. 11-13. The control handle 350 incorporates an actuator 352 thatpivots about a pin 354. A lever arm 356 projecting into the handle 350from the actuator 352 engages a control rod 358. The control rod 358extends distally through a flexible shaft 360 to open and close distaltissue welding jaws (not shown), such as described above. The lever arm356 may be bifurcated, for example, such that its ends straddle thecontrol rod 358 between a proximal ball 362 a and a distal ball 362 b. Aspring 364 concentrically surrounds the control rod 358 and isinterposed between the lever arm 356 and the proximal ball 362 a.

When the actuator 352 is rotated in a clockwise direction, such as seenin FIG. 15A, the lever arm 356 moves in a leftward direction against thespring 364, which in turn acts against the proximal ball 362 a. As longas the reaction force on the jaws is less than the spring constant, thespring 364 remains uncompressed and moves as a rigid body. Thisdirection of travel of the control rod 358 corresponds to closing of thedistal jaws. If the jaws close upon tissue, or are otherwise preventedfrom further closure, the reaction force through the control rod 358eventually becomes greater than the spring constant, and the lever arm356 compresses the spring 364 against the proximal ball 362 a.

Although the lever arm 356 continues to move, it does not translatemovement to the control rod 358 and the jaw force clamping the tissueremains constant. Conversely, counter-clockwise rotation of the actuator352, such as seen in FIG. 15B, causes the lever arm 356 to travel to theright- and act directly on the distal ball 362 b; Because the distalball 362 b is fixedly attached to the control rod 358, pivoting movementof the actuator 352 directly translates into linear displacement of thecontrol rod, which opens the jaws. This arrangement is similar to theforce-limiting configuration described above with respect to FIGS.11-13.

In a slight variation to the embodiment of FIGS. 15A and 15B, the leverarm 356 itself may be formed as a spring in lieu of the coil spring 364.In such an alternative, the lever arm 356 is a metallic or moldedplastic leaf spring that is bifurcated around the control rod 358.Application of a closing force eventually causes the lever arm 356 tobend, therefore limiting the applied clamping force at the jaws. Toensure that the lever arm 356 bends consistently at a predeterminedforce, it may be formed with a concavity (similar to a reed for a windinstrument) for added structural rigidity enabling it to resist bucklinglonger until reaching a discreet load.

FIGS. 16A and 16B illustrates an alternative variation of aforce-limiting configuration. An actuator 370 includes a rigid portion,defined by a thumb lever 372 and a lever arm 374, that pivots about apin 376. A second thumb lever 378 also pivots about the pin 376 and isconnected via a coil spring 380 to the lever arm 374. Although notshown, a control rod attached to open and close distal tissue weldingjaws is coupled to move with the distal end of the lever arm 374.Depressing the thumb lever 372 in a counter-clockwise direction as shownin FIG. 16A causes the lever arm 374 to translate to the right,corresponding to linear movement of the control rod to open the distaljaws. On the other hand, depressing the second thumb lever 378 in aclockwise direction as seen in FIG. 16B causes the lever arm 374 andcontrol rod to translate to the left, and thus open the distal jaws.Eventually, a reaction force from the jaws transmitted from the controlrod to the lever arm will be sufficient to cause the coil spring 380 tocompress, thus effectively decoupling movement of the second thumb lever378 from movement of the distal jaws. Again, the clamping force on thetissue remains constant after the spring 380 begins to compress.

FIGS. 17A and 17B illustrate an alternative force-limiting actuator 390having a rigid portion defined by an extension 392 and a lever arm 394.The rigid portion pivots about a pin 396, about which also pivots athumb lever 398 having wings extending in opposite directions.Depressing one of the wings of the thumb lever 398 in acounter-clockwise direction as indicated in FIG. 17A acts on theextension 392 which causes the lever arm 394 to translate to the rightand move a control rod linearly (not shown). The control rod, in turn,opens the distal tissue welding jaws. Depressing the opposite wing in aclockwise direction as seen in FIG. 17B causes a leaf spring 400 tocontact one side of the lever arm 394. As the lever arm 394 translatesto the left, and pulls the control rod, the jaws close. Eventually,closure of the jaws on tissue results in a reaction force beingtransmitted through the control rod which resists further movement ofthe lever arm 394. If the user depresses the wing of the thumb lever 398farther, the leaf spring 400 merely bends.

An alternative force-limiting structure provided within the controlhandle that is not specifically illustrated includes a pair of magnetsthat repel one another. For example, in FIGS. 17A and 17B the lever arm394 and thumb lever 398 may carry magnets with like poles facing oneanother such that when the thumb lever 398 pivots in a clockwisedirection the opposite magnets provide resistance against furtherclosing motion.

Another variation of a force-limiting structure incorporated into acontrol handle is seen in FIG. 18. An actuator includes a rigid portionhaving a lever arm 410 and a perpendicular extension 412. The rigidportion pivots about a shaft 414 about which also pivots a thumb lever416 having opposite wings. A pin or other such projection 418 extendsperpendicularly from the right-hand wing of the thumb lever 416 so as toengage the extension 412. The distal ends of the right-hand wing and theextension 412 are connected by a coil spring 420. Depressing theright-hand wing of the thumb lever 416 causes the pin 418 to contact andpivot the extension 412 about the shaft 414, thus moving a control rod422 connected to the lever arm 410. Depressing the left-wing of thethumb lever 416 rotates the extension 412 in a clockwise direction aboutthe shaft 414 until such time as a reaction force through the controlrod 422 and lever arm 410 causes the coil spring 420 to expand.

Instead of the interposition on a spring between a thumb lever and acontrol rod, a clutch may be provided which completely decouplesrelative movement there between. For example, FIG. 19 illustrates anarrangement similar to that shown in FIG. 18, but instead of the coilspring 420 a ball detent 430 is provided on the rigid portion of theactuator. The ball detent 430 engages the left-hand wing when the thumblever 416 pivots in a counterclockwise direction. At a thresholdreaction force, the ball detent 430 slips so that the thumb lever 416 nolonger acts on the control rod.

Another variation of a clutch configuration is seen in FIG. 20. In thisversion, a toothed rack 440 is mounted on a proximal end of the controlrod 442 within the control handle (represented by a frame 443). Anactuator 444 includes a spring-loaded pin 446 that engages the toothedrack 440. Movement of the actuator 444 to the left or right causesequivalent movement of the toothed rack 440, and control rod 442. Iftissue within the distal jaws causes the control rod 442 to stop moving,eventually the pin 446 moves upward against its spring and cams out ofthe teeth of the rack 440. A second spring 448 may be attached betweenthe frame 443 and actuator 444 to provide a return force in onedirection.

FIG. 21 illustrates an alternative configuration of a spring for use asa force-limiting member. In this embodiment, a tubular control rod 450provides the spring itself. Namely, a laser cut spiral 452 in thecontrol rod 450 results in a helical section designed to compress orextend upon a predetermined force being applied to the control rod. Thisconfiguration therefore eliminates a separate coil spring around thecontrol rod. In a further alternative to forming a spring within thecontrol rod 450, a segment or all of a control rod may be made fromsuper-elastic material such as Nitinol which undergoes a phasetransition and stretches after application of a threshold tensile force.Desirably, in the latter arrangement a separate rigid push rod may beprovided to open the jaws in conjunction with the super-elastic pull rodwhich limits the force that can be applied when closing the jaws. In oneparticular embodiment, a 30 cm long super-elastic pull rod undergoesapproximately 5% elongation (1.5 cm) without exceeding its elastic limit(usually 6% with Nitinol), which therefore permits further actuatortravel without applying more force to the closed jaws. Again, withelastic force-limiting members, a constant force is applied to tissuebetween the jaws after they close.

FIG. 22A illustrates an alternative force-limiting configuration for atissue welder of the present invention which is not located within acontrol handle 460. An actuator 462 includes a lever arm 464 that actsin opposite directions on two balls fixed to an actuator rod 466. Theactuator rod extends into a flexible shaft 468 and is fixedly attachedto a distal block 470 therein. A small flange 472 is also provided onthe actuator rod 466. A proximal block 474 includes a through bore thatreceives the actuator rod 466. A control rod 476 is fixedly attached tothe proximal block 474 and continues in a distal direction through abore in the distal block 470. A coil spring 478 surrounds both theactuator rod 466 and control rod 476 in the area between the distal andproximal blocks 470, 474.

Rotation of the actuator 462 in the clockwise direction as shown causesthe lever arm 464 to act on the proximal ball and translate the actuatorrod 466 to the left. This movement pulls the distal block 470 to theleft, as indicated and also through the spring 478 causes the proximalblock 474 and control rod 476 to move leftward. Typically this movementcorresponds to closure of distal tissue welding jaws. At some point, thejaws close or close on tissue and resist further leftward movement ofthe control rod 476. Further movement of the actuator rod 466 merelycompresses the spring 478. This is the situation shown in FIG. 22A inwhich a space S is indicated between the flange 472 and the proximalblock 474. Rotation of the actuator 462 in the opposite direction actson the distal ball of the actuator rod 466 causing it to move distallyto the right. In this case, the flange 472 acts directly on the proximalblock 474 and pushes the control rod 476 an equivalent distance to theright (this is shown for the alternative configuration of FIG. 22B).

FIG. 22B shows a slight variation on the force-limiting configuration ofFIG. 22A which incorporates not only a first coil spring 478 but also asecond coil spring 480. The two springs 478, 480 provide two differentspring rates such that regulation of closing of the distal jaws occursin two stages. Namely, the first spring 478 compresses when the distaljaws provide a first reaction force. The user senses this resistance andthus knows when tissue is clamped between the jaws. Further compressionof the spring 478 ultimately results in compression of the second spring480, having a higher spring rate. The second spring 480 can be used todifferentiate activation of a switch, for instance, to weld or forfasciotomy, or just as a detent to differentiate between grasping andwelding.

Now with reference to FIG. 23, a pair of tissue welding jaws 500 isshown schematically attached to the end of the control rod 502. Aportion of the control rod has a voice coil 504 thereon surrounded by amagnet 506. This assembly provides an electromotive actuator 508 fortranslating the control rod 502 in proximal and distal directions uponrunning a current through the voice coil 504. In this embodiment, areturn spring 510 connects the control rod 502 to a control handle,represented by a fixed point 512. The strength of the electromotiveactuator 508 is desirably calibrated to be more than the minimumrequired to weld tissue within the jaws 500 but less than a force whichwould unduly damage the tissue. The strength of the electromotiveactuator 508 can be controlled by choice of coil 504 or magnet 506, orby regulating the current supplied to coil. The electromotive actuator508 may be arranged as a solenoid or voice coil, whichever provides thedesired response.

FIG. 24 illustrates a force-limiting leaf spring 520 provided withinsoft material 522 of one of the tissue welding jaws 524. A heatingelement 526 is illustrated on the opposite jaw. Closure of the jaws 524with tissue there between eventually causes the leaf spring 520 to bend,thus limiting the amount of force that can be applied to the tissue.

In FIG. 25, a similar arrangement as that in FIG. 24 has a series ofbi-metallic inserts 530 mounted within one of the jaws that includes theheating element 532. The bi-metallic inserts 530 are U-shaped and thetwo materials are chosen so that upon heating their differentialexpansion rates cause the inserts to straighten out. The jaws arearranged so that at their closest a gap 534 exists. Upon actuation ofthe heating element 532, the bi-metallic inserts 530 straighten out fromtheir U-shaped configuration, thus forcing the heating element 532against the tissue within the gap 534. Careful control of the dualmaterials of the bi-metallic inserts 530 and/or the amount of heatsupplied by the heating element 532 ensures that proper welding occurswithout tissue damage. In general, an elastic member(s) provided in oneor both jaws is adapted to change shape at elevated temperatures. Forexample, instead of bi-metallic inserts 530, a U-shaped member formed ofa shape memory alloy with a phase transition temperature adjusted to themaximum heating element temperature may be utilized.

FIGS. 26A and 26B illustrate a still further version of an arrangementfor limiting the amount of force applied to tissue that is incorporatedwithin a pair of tissue welding jaws 540. A rigid tissue contactingplate 542 attaches to one of the jaws via an elastomeric layer 544 (theopposite jaw carries the heating element). FIG. 26B depicts compressionof a blood vessel 546 within the jaws 540. At some point of jaw closure,the elastomeric layer 544 deforms to limit the amount of force appliedto the vessel 546. In addition, the compliant character of theelastomeric layer 544 is such that it compresses more toward theproximal ends of the jaws 540 and thus helps maintain parallelismbetween the tissue contacting plate 542 and the opposite jaw. Statedanother way, upon jaw closing the compliant middle layer 544 compressesunevenly such that the rigid tissue contacting plate 542 floats on itsjaw 540 and helps even out clamping pressure on the vessel 546. Thisarrangement not only limits force but also helps ensure even heating ofthe vessel 546 in a proximal-distal direction.

FIG. 27 schematically illustrates a mechanism 550 for maintainingparallelism of a pair of jaws 552. Translation of a pair of pins 554within angled guide brackets 556 ensures that a first jaw 558 having aheating element 560 thereon remains parallel to an opposite jaw 562.This results in more even heating of the vessel 564 between the jaws552, at least in a proximal-distal direction. It should be noted herethat the mechanism 550 for maintaining parallelism of the jaws 552 canbe coupled with any of the force-limiting configurations disclosedherein.

FIG. 28 illustrates an arrangement for both limiting the force that isapplied to tissue between a pair of jaws 570 a, 570 b and maintainingparallelism between the jaws. The proximal ends of the jaws 570 a, 570 bare illustrated at the distal end of a flexible shaft 572 that houses acontrol rod 574. Much like the movement mechanism seen in FIGS. 14A-14Cthe control rod 574 is connected to a pin 576 that translates in aproximal-distal line and acts on a pair of angled slots 578 formed inthe jaws 570 a, 570 b. The jaws 570 a, 570 b are shown open with the pin576 to the right end of the slots 578, and movement of the pin in aproximal direction closes the jaws. A jaw pivot shaft 580 is receivedwithin a transverse slot 582 formed in a first one of the jaws 570 a,while the second jaw 570 b pivots about the shaft 580 as a fixed point.That is, the position of the shaft 580 is fixed with respect to thesecond jaw 570 b but translates along the slot 582 with respect to thefirst jaw 570 a. A spring 584 normally maintains the shaft 580 at thebottom of the slot 582, and thus biases the proximal ends of the jawstogether.

Upon closure of the jaws 570 a, 570 b on tissue, the proximal end of thesecond jaw 570 b and the shaft 580 will be forced upward against theforce of the spring 584, thus separating the proximal ends of the jaws.The reader will understand that the strength of the spring 584 may becalibrated to yield within a particular range of closing forces. Forexample, if the jaws 570 a, 570 b are being used to weld relativelysmall vessels or delicate tissue, the spring 584 has a slight stiffness,but application to larger vessels or more fibrous tissue may require agreater spring force. At the same time, other factors such as the shapeof the jaws 570 a, 570 b or magnitude of heat applied may also affectthe choice of spring 584.

Now with reference to FIG. 29, an actuator 590 configured to displace acontrol rod 592 at a non-linear rate is shown. The actuator 590 may bemounted to pivot about a shaft 594 within a control handle, such as wasdescribed previously. The proximal end of the control rod 592 carries apin 596 positioned to travel within an arcuate cam slot 598 formed in anextension of the actuator 590. Through rotation of the actuator 590about the shaft 594, the control rod 592 displaces as the pin 596follows the cam slot 598, thus opening and closing distal tissue weldingjaws. The reader will understand that, because of the shape of the camslot 598 and its spatial relationship with respect to the shaft 594, thedistance that the control rod 592 translates along its axis decreases asthe actuator 590 rotates in a clockwise direction (indicated by arrow599). Conversely, the distance the control rod 592 translates along itsaxis increases when the actuator 590 rotates in a counter-clockwisedirection. This variable or non-linear rate of travel of the control rod592 may be beneficially coordinated with movement of the jaws so that asthe jaws begin to come together their rate of closure decreases, orslows down. Conversely, as the jaws begin to open their rate ofseparation increases, or speeds up. This configuration may also becoupled with a force-limiting spring, for example, to automatically slowdown the jaw closing phase and thus compress tissue with greater care.

In addition to regulating the movement of the jaws, and their closingforce, the construction of each of the jaws may be designed to focusheat or enhance their welding and severing efficiency. To understandseveral different configurations in this regard, FIGS. 30A and 30Billustrate a symmetric pair of jaws 600 each having an inner jaw 602surrounded by a tissue-contacting boot 604. The symmetric jaws 600 areseen closing on a vessel 606 in FIG. 30B. A heating element is notshown, though any of the various configurations described herein may becoupled with the symmetric jaws 600 to weld and/or sever the vessel 606.

FIGS. 31A and 31B offer an alternative to the symmetric jaws 600,wherein a standard jaw 610 faces a relatively more narrow jaw 612. Thatis, the standard jaw 610 has a transverse width substantially greaterthan the narrow jaw 612. In this regard, the narrow jaw 612 has an innerjaw member 614 surrounded by a tissue-contacting boot 616, both areshown proportionately reduced in size from the standard jaw 610,preferably by at least 20%. When the jaws 610, 612 close on tissue, suchas the vessel 618 seen in FIG. 31B, the reduced width of the narrow jaw612 reduces the tissue contacting surface and causes a shearing actionof sorts such that the vessel falls away on either side. Thisarrangement therefore helps sever the vessel 618 after it has beenwelded, and helps reduce tissue sticking to the jaws.

FIGS. 32 and 33 respectively illustrate a contrast between a standardpair of jaws 620 a, 620 b and an alternative pair 622 a, 622 b. Thestandard jaws 620 a, 620 b are similar to those shown in FIG. 30A, butalso include a heating element 624 provided on a facing surface of theupper jaw 620 a. The standard jaws 620 a, 620 b have generallysemi-circular cross-sections with the flat sides facing one another. Incontrast, the alternative jaws 622 a, 622 b have the same inner jaws 626with their flat sides facing one another, but the surroundingtissue-contacting boots 628 are rotated 180° such that there curvedsides face one another. Because the rounded surfaces of the boots 620form the tissue-contacting surfaces, the transverse width of tissue thatis clamped between the jaws is reduced. This focuses the pressureapplied to the tissue during thermal tissue welding along more of a linecentered on the heating element 624. Higher pressure at the heatingelement facilitates cutting of the tissue by both increasing heattransfer to the tissue and mechanical separation because of the higherpressure. The smaller tissue-contacting area also helps reduce tissuesticking to the jaws.

FIGS. 34A and 34B illustrate jaws 640 a, 640 b in open and closedpositions, respectively, that incorporate several of the conceptsdisclosed above. A first jaw 640 a includes a rigid portion 642 and acompliant or malleable pad 644 on its jaw facing surface. The second jaw640 b includes a rigid portion 646 supporting a contoured heatingelement 648 on its jaw facing surface. A plurality of force arrows 650represent the application of uniform pressure to the upper side of thefirst jaw 640 a, such as through the use of fluid-mechanics (e.g.,pneumatics or hydraulics). Specifically, a fluid-mechanical driver (notshown) would be connected between the control actuator of the handle andthe jaws 640 a, 640 b and is adapted to translate movement of thecontrol actuator into movement of the jaws. When the jaws 640 a, 640 bclose, as seen in FIG. 34B, the malleable pad 644 conforms to thecontour of the heating element 648. The heating element has a transversewidth 652 and a central protrusion 654 flanked by a pair of flatsurfaces 656. The flat surfaces 656 function as welding elements, whilethe protrusion 654 acts as a cutting element because of its higherprofile.

FIG. 35 is a graph schematically indicating the temperature profilewithin tissue held between the jaws 640 a, 640 b across their transversewidth. The graph indicates a rise in the temperature in the tissueacross the entire heating element 648, with a spike in the centercorresponding to the protrusion 654. Assuming the material of theheating element 648 is uniform, the temperature of the heating elementwill also be uniform, but because of the higher pressure and thermalgradients in the tissue, the temperature in the tissue will be greaterin the center. Of course, one potential alternative is to form theprotrusion 654 as a different material than the rest of the heatingelement 648 so that the protrusion reaches a higher temperature. FIG. 36is a graph schematically illustrating the pressure distribution withintissue held between the jaws 640 a, 640 b across their transverse width.Again, the pressure increases in the region of the heating element 648,and spikes in the center due to the raise protrusion 654.

A temperature and pressure distribution similar to that resulting fromthe jaw configuration of FIGS. 34A and 34B may be obtained usingseparate heating elements, such as shown in FIGS. 37 and 38. Forinstance, a narrow heating element 660 is positioned between a pair offlanking heating elements 662 on one of the jaws shown in FIG. 37. Thetemperature and pressure profiles obtained depend on how large thenarrow heating element 660 is with respect to the flanking heatingelements 662, and also on properties of the material, such as electricalresistance. It should also be understood that the flanking heatingelements 662 may be actively heated, such as was described above, orthey may be passively heated indirectly from heat generated by thenarrow heating element 660. The jaws shown in FIG. 38 include a narrowheating element 670 on one jaw and a relatively wider heating element672 on the opposite jaw. The narrow heating element 670 is positioned atthe approximate transverse centerline of the wider heating element 672.When the jaws are brought together, the pressure and temperature aregreatest between the two heating elements 670, 672, which thereforeprovides the tissue severing action. Once again, the wider heatingelement 672 may be actively or passively heated and acts as a tissuewelding element. It should be noted that if the wider heating element672 is actively heated, structure to electrically insulate the twoelements during use will likely be provided.

FIG. 39 illustrates an alternative jaw 680 in which a heating element682 is partially embedded within an outer boot 684. This smootherprofile increases the transition angle between the heating element 682and the boot 684 and thus helps enhance tissue release. Morespecifically, this smoother transition from heating element 682 to theinsulating boot 684 reduces the amount of char that collects at the edgeof the heating element, thereby reducing adhesion (sticking) of tissueto the jaws. Sticking may increase weld time and can result in damage tothe weld band as the jaws are removed from the vessel.

Another configuration for tissue welding jaws that helps release severedtissue is seen in FIGS. 40A and 40B. Each of the illustrated jawsincludes a small flap 690 that projects toward the other jaw. The flap690 may be formed as part of the insulating boot, or may extend from themore rigid inner jaw. Further, only one or both of the jaws may featurea flap 690. When the jaws close, as seen in FIG. 40B, the flaps 690overlap to the side of the opposite jaw and push the vessel or tissueoff of the jaws upon completion of the weld. This reduces weld time andsticking.

The present invention also contemplates a number of alternative controlmechanisms that enhance ergonomics or user-friendliness of theaforementioned devices. For example, in FIGS. 41A and 41B a lockingfeature in a toggle switch is provided so that the user need notmaintain pressure on the jaws during the welding/severing process. Atoggle or actuator 700 includes a small slot 702 that pivots andtranslates with respect to a shaft 704 fixed on a control handle (notshown). A lower end of the actuator 700 is secured at a point 706 to aflexible (e.g., Nitinol) control wire 708. The movement of the controlwire 708 is seen in the two figures relative to movement of the actuator700. The actuator includes a small pin 710 that translates within anL-shaped slot 712 formed as part of the control handle. FIG. 41A showsthe actuator 700 in a position wherein the pin 710 is at the end of thelong portion of the slot 712, and corresponds to the jaw open state ofthe device. In addition, the actuator 700 is biased so that the shaft704 is normally at the top of the slot 702.

Upon rotation of the actuator 700 in the counter-clockwise direction,the pin 710 translates along the channel 712 into the position shown inFIG. 41B by virtue of the spring bias on the actuator 700. The pin 710remains in the short, angled portion of the channel 712 while the jawsare closed and the tissue is being welded. The user must first depressthe actuator downward to release the actuator 700 and open the jaws.

Another arrangement for locking an actuator 720 during thewelding/severing phase is seen in FIGS. 42A and 42B. The actuator pivotsabout a shaft 722 within a control handle (not shown) and translates acontrol rod 724. A locking feature 726 is provided on an extension ofthe actuator 720 to engage a pin 728 fixed in the control handle. Asseen in FIG. 42B, the actuator 720 may be locked in a clockwise positioncorresponding to the jaws being closed.

An actuator specially designed to facilitate fasciotomy can beunderstood by comparing FIGS. 43A and 43B. The actuator 730 in FIG. 43Ais similar to those described above with respect to FIGS. 11-13, andpivots about a shaft 732 fixed with respect to a control handle (notshown). The actuator 730 includes a through bore that receives a controlrod 734 leading to distal tissue welding jaws. As the actuator 730pivots in a clockwise direction as shown, a cam lobe 736 acts on a camfollower 738 attached to the control rod 734. The round profile of thecam lobe 736 pushes the follower 738 and rod 734 distally to the rightto fully open the jaws.

FIG. 43B illustrates a modified actuator 730′ that includes a recessedregion 740 in the upper part of the cam lobe 736. As the actuator 730′continues rotating in a clockwise direction, the jaws open buteventually the cam follower 738 reaches the recess 740 and translates asmall distance in the opposite direction to slightly close the jaws.After the actuator 730′ has pivoted its full extent, the user mayactuate a switch for fasciotomy. Because the cam follower 738 hasretreated proximally a small distance, the jaws are not fully open sothat there is less interference with the surrounding tissue cavity andmore maneuverability of the jaws. The angle at which the jaws remainopen during fasciotomy may be optimized based on the contour of therecess 740.

Fasciotomy using the tissue welding jaws of the present invention mayalso be enhanced by uneven control of one jaw with respect to the other.That is, much like the design seen in FIGS. 43A and 43B, there are othermechanisms for controlling the angle of the jaw having the cuttingelement thereon so that it more effectively faces the fascia to be cut.For example, the exemplary movement mechanism described above withrespect to FIG. 4 may be modified so that the hot jaw 40 assumes anangle that facilitates fasciotomy. Namely, the angled slots 68 may beangled differently such that linear movement of the yolk 114 translatesand unequal jaw opening motion. The hot jaw may be opened up to asteeper angle than the cold jaw. Another contemplated mechanism is anasymmetric two-bar linkage system such that the jaws open unevenly.

The present invention also contemplates a variety of means foractivating safety interlocks for the electric circuits for the heatingelements for welding, severing, or fasciotomy, such that the heatingelements can only be actuated upon movement of the control actuator tofully close the jaws. For example, FIG. 44 discloses a toggle oractuator 750 having a conductive strip 752 on an underside positioned tocontact and connect two pads 754 mounted within a control handle (notshown). Connecting the two pads 754 closes a safety interlock circuitsuch that another switch may then be actuated to energize thewelding/severing heating elements. In this way, the user cannot energizethe heating elements without the actuator being depressed, correspondingto the jaws being closed. An alternative arrangement of a safetyinterlock is seen in FIG. 45 wherein an actuator 760 carries aprotrusion 762 positioned to contact the moving element 764 of amicroswitch 766. Actuating the microswitch 766 enables separateactivation of a heating element. Finally, FIG. 46 shows a thirdalternative wherein an actuator 770 carries a protrusion 772 that actson a leaf spring 774 to close a safety interlock circuit. The leafspring 774 may be enclosed or embedded by a fluid seal 776, such as asilicone membrane.

Two other safety interlock configurations are illustrated in FIGS. 47and 48. In both of these, an actuator 780 pivots to translate a controlrod 782, as has been previously described. In FIGS. 47A and 47B thecontrol rod 782 eventually actuates a microswitch 784 at itsproximal-most travel. The microswitch 74 may be part of a safetyinterlock circuit, or may be the heating element activation switch. InFIGS. 48A and 48B, the control rod 782 carries a conductive strip 786that contacts a conductive pad 788 at the proximal end of its travel. Inthis embodiment, the control rod 782 is conductive and itself forms apart of a safety interlock circuit.

It will also be appreciated by those of skill in the relevant art thatvarious modifications or changes may be made to the examples andembodiments described without departing from the intended scope of theinvention. In this regard, the particular embodiments of the inventiondescribed herein are to be understood as examples of the broaderinventive concept disclosed.

What is claimed:
 1. A surgical apparatus comprising: a shaft; a firstjaw and a second jaw extending from a distal end of the shaft andrelatively movable with respect to one another; and an electrode forminga heating element associated with one jaw of the first jaw and thesecond jaw, wherein the heating element has a contour that comprises aprotrusion extending towards the other jaw of the first jaw and thesecond jaw and a pair of substantially flat surfaces, wherein theprotrusion is flanked on each side by the substantially flat surfaces ofthe heating element so that when the first jaw and the second jaw closeto hold tissue between the first jaw and the second jaw, the protrusionis heated to cut the tissue and the substantially flat surfaces areheated to weld the tissue, wherein a malleable pad is disposed on theother jaw so that when the first jaw and the second jaw are closed tohold the tissue the malleable pad conforms to the contour of the heatingelement.
 2. The surgical apparatus of claim 1, wherein the protrusionand the substantially flat surfaces are made of the same material. 3.The surgical apparatus of claim 2, wherein the protrusion and thesubstantially flat surfaces are formed from a sheet of material ofsubstantially uniform thickness.
 4. The surgical apparatus of claim 1,wherein the protrusion and the substantially flat surfaces are made ofdifferent materials so that the protrusion heats to a higher temperaturethan the substantially flat surfaces.
 5. The surgical apparatus of claim1, wherein the electrode is associated with the first jaw and themalleable pad is disposed on the second jaw.
 6. The surgical apparatusof claim 1, wherein the electrode is supported by a rigid portion of theone jaw and the malleable pad is supported by a rigid portion of theother jaw.
 7. The surgical apparatus of claim 1, wherein the protrusionis aligned along the center of the heating element.
 8. The surgicalapparatus of claim 7, wherein the heating element has a uniformresistance and heats to a uniform temperature per unit of surface area,wherein when the first jaw and the second jaw are closed on the tissue,the protrusion of the heating element exerts a higher pressure and ahigher power density to the tissue than does the substantially flatsurfaces.
 9. The surgical apparatus of claim 1, wherein the heatingelement has a uniform resistance and heats to a uniform temperature perunit of surface area.
 10. The surgical apparatus of claim 9, whereinwhen the first jaw and the second jaw are closed on the tissue, theprotrusion of the heating element exerts a higher pressure and a higherthermal gradient to the tissue than does the substantially flatsurfaces, and the first jaw and the second jaw are sized to fit througha 5 mm port.
 11. The surgical apparatus of claim 10, wherein when thefirst jaw and the second jaw are closed on the tissue, the protrusionexerts a pressure spike on the tissue that is sharper than a temperaturespike exerted by the protrusion on the tissue, and the first jaw and thesecond jaw each have a lengthwise curvature and jaw-facing surfaces thatcontact one another along a curved line.
 12. The surgical apparatus ofclaim 9, wherein when the first jaw and the second jaw are closed on thetissue, the protrusion of the heating element creates an area of higherpressure and higher power density in the tissue during heating than thesubstantially flat surfaces, and the first jaw and the second jaw eachhave a lengthwise curvature.
 13. The surgical apparatus of claim 1,wherein the heating element is disposed on a surface of the first jaw orthe second jaw that is facing the other jaw.
 14. The surgical apparatusof claim 1, wherein the protrusion extends along the length of the firstjaw or the second jaw.
 15. The surgical apparatus of claim 1, whereinthe electrode is supported by a rigid portion of the one jaw and facesthe other jaw, so that when the first jaw and the second jaw are closedto hold the tissue, the protrusion of the heating element creates anarea of higher pressure in the tissue than the substantially flatsurfaces of the heating element.
 16. A surgical apparatus comprising: ashaft; a first jaw and a second jaw extending from a distal end of theshaft and relatively movable with respect to one another; and anelectrode forming a heating element associated with one jaw of the firstjaw and the second jaw, wherein the heating element has a contour thatcomprises a protrusion extending towards the other jaw of the first jawand the second jaw and a pair of substantially flat surfaces, whereinthe protrusion is flanked on each side by the substantially flatsurfaces of the heating element so that when the first jaw and thesecond jaw close to hold tissue between the first jaw and the secondjaw, the protrusion creates an area of higher pressure and higher powerdensity in the tissue during heating than the substantially flatsurfaces, and the protrusion and the substantially flat surfaces areformed from a sheet of material so that the protrusion and thesubstantially flat surfaces are made of the same material.
 17. Asurgical apparatus comprising: a shaft; a first jaw and a second jawextending from a distal end of the shaft and relatively movable withrespect to one another; and an electrode forming a heating elementassociated with one jaw of the first jaw and the second jaw, wherein theheating element has a contour that comprises a protrusion extendingtowards the other jaw of the first jaw and the second jaw and a pair ofsubstantially flat surfaces, wherein the protrusion is flanked on eachside by the substantially flat surfaces of the heating element so thatwhen the first jaw and the second jaw close to hold tissue between thefirst jaw and the second jaw, the protrusion is heated to cut the tissueand the substantially flat surfaces are heated to weld the tissue,wherein the protrusion and the substantially flat surfaces are made ofthe same material and are formed from a sheet of the material ofsubstantially uniform thickness.
 18. A surgical apparatus comprising: ashaft; a first jaw and a second jaw extending from a distal end of theshaft and relatively movable with respect to one another; and anelectrode forming a heating element associated with one jaw of the firstjaw and the second jaw, wherein the heating element has a contour thatcomprises a protrusion extending towards the other jaw of the first jawand the second jaw and a pair of substantially flat surfaces, whereinthe protrusion is flanked on each side by the substantially flatsurfaces of the heating element so that when the first jaw and thesecond jaw close to hold tissue between the first jaw and the secondjaw, the protrusion is heated to cut the tissue and the substantiallyflat surfaces are heated to weld the tissue, wherein the protrusion andthe substantially flat surfaces are made of the same material and theheating element has a uniform resistance and heats to a uniformtemperature per unit of surface area, and a malleable pad is disposed onthe other jaw so that when the first jaw and the second jaw are closedto hold the tissue the malleable pad conforms to the contour of theheating element, wherein when the first jaw and the second jaw areclosed on the tissue, the protrusion of the heating element exerts ahigher pressure and a higher thermal gradient on the tissue than doesthe substantially flat surfaces and the protrusion exerts a pressurespike on the tissue that is sharper than a temperature spike exerted bythe protrusion on the tissue.